An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial
Objectives Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo...
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| Published in: | Current controlled trials in cardiovascular medicine Vol. 21; no. 1; pp. 847 - 3 |
|---|---|
| Main Authors: | , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
London
BioMed Central
13.10.2020
BioMed Central Ltd Springer Nature B.V BMC |
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| ISSN: | 1745-6215, 1745-6215 |
| Online Access: | Get full text |
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| Abstract | Objectives
Primary objective:
To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation
Secondary objectives:
• To determine the safety of the antiviral
• To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale
• To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms
• To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation
Trial design
This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1.
Participants
Inclusion Criteria:
• Provision of informed consent by the participant
• Age ≥18 years
• Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days
• COVID-19 related symptom initiation within 5 days
• Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.
Exclusion criteria:
• Known allergy to the study medication
• Is on another clinical trial investigating an antiviral treatment for COVID-19
• Pregnancy
• Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification
• Patients with renal impairment requiring dialysis
• Is deemed by the Investigator to be ineligible for any reason
Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation.
Intervention and comparator
The first candidate antiviral is favipiravir
Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days.
Arm 2: Placebo
Main outcomes
Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment.
Randomisation
Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site.
Blinding (masking)
Study participants, study investigators and the study statistician will be blinded to treatment allocation.
Numbers to be randomised (sample size)
The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir
Trial Status
Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020.
Trial registration
clinicaltrials.gov
NCT04445467
First posted 24-Jun-2020
Full protocol
The full protocol is attached as an additional file, accessible from the Trials website (Additional file
1
). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. |
|---|---|
| AbstractList | Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Inclusion Criteria: The first candidate antiviral is favipiravir Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment. Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation TRIAL DESIGN: This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1.OBJECTIVESPrimary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation TRIAL DESIGN: This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1.Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.PARTICIPANTSInclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.• Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation.EXCLUSION CRITERIA• Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation.The first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo MAIN OUTCOMES: Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment.INTERVENTION AND COMPARATORThe first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo MAIN OUTCOMES: Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment.Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site.RANDOMISATIONRandomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site.Study participants, study investigators and the study statistician will be blinded to treatment allocation.BLINDING (MASKING)Study participants, study investigators and the study statistician will be blinded to treatment allocation.The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS: Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020.NUMBERS TO BE RANDOMISED (SAMPLE SIZE)The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS: Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020.clinicaltrials.gov NCT04445467 First posted 24-Jun-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.TRIAL REGISTRATIONclinicaltrials.gov NCT04445467 First posted 24-Jun-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Objectives Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation Trial design This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1. Participants Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment. Exclusion criteria: • Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation. Intervention and comparator The first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo Main outcomes Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment. Randomisation Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site. Blinding (masking) Study participants, study investigators and the study statistician will be blinded to treatment allocation. Numbers to be randomised (sample size) The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir Trial Status Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020. Trial registration clinicaltrials.gov NCT04445467 First posted 24-Jun-2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Abstract Objectives Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation Trial design This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1. Participants Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment. Exclusion criteria: • Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation. Intervention and comparator The first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo Main outcomes Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment. Randomisation Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site. Blinding (masking) Study participants, study investigators and the study statistician will be blinded to treatment allocation. Numbers to be randomised (sample size) The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir Trial Status Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020. Trial registration clinicaltrials.gov NCT04445467 First posted 24-Jun-2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Objectives Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: * To determine the safety of the antiviral * To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale * To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms * To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation Trial design This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1. Participants Inclusion Criteria: * Provision of informed consent by the participant * Age [greater than or equai to]18 years * Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days * COVID-19 related symptom initiation within 5 days * Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment. Exclusion criteria: * Known allergy to the study medication * Is on another clinical trial investigating an antiviral treatment for COVID-19 * Pregnancy * Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification * Patients with renal impairment requiring dialysis * Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation. Intervention and comparator The first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo Main outcomes Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment. Randomisation Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site. Blinding (masking) Study participants, study investigators and the study statistician will be blinded to treatment allocation. Numbers to be randomised (sample size) The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir Trial Status Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020. Trial registration clinicaltrials.gov NCT04445467 First posted 24-Jun-2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Keywords: COVID-19, Randomised controlled trial, protocol, favipiravir, treatment, community, adaptive ObjectivesPrimary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisationSecondary objectives:• To determine the safety of the antiviral• To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale• To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms• To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activationTrial designThis is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1.ParticipantsInclusion Criteria:• Provision of informed consent by the participant• Age ≥18 years• Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days• COVID-19 related symptom initiation within 5 days• Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.Exclusion criteria:• Known allergy to the study medication• Is on another clinical trial investigating an antiviral treatment for COVID-19• Pregnancy• Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification• Patients with renal impairment requiring dialysis• Is deemed by the Investigator to be ineligible for any reasonParticipants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation.Intervention and comparatorThe first candidate antiviral is favipiravirArm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days.Arm 2: PlaceboMain outcomesPrimary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment.RandomisationRandomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site.Blinding (masking)Study participants, study investigators and the study statistician will be blinded to treatment allocation.Numbers to be randomised (sample size)The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravirTrial StatusProtocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020.Trial registrationclinicaltrials.gov NCT04445467First posted 24-Jun-2020Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation TRIAL DESIGN: This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1. Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment. • Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation. The first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo MAIN OUTCOMES: Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment. Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site. Study participants, study investigators and the study statistician will be blinded to treatment allocation. The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS: Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020. clinicaltrials.gov NCT04445467 First posted 24-Jun-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. |
| ArticleNumber | 847 |
| Audience | Academic |
| Author | Lau, Jillian S. Y. Roney, Janine Gardiner, Bradley Peleg, Anton Y. McMahon, James H. Molton, James S. Cheng, Allen Rogers, Benjamin A. Sasadeusz, Joseph Lee, Sue J. Hoy, Jennifer F. Trubiano, Jason |
| Author_xml | – sequence: 1 givenname: James H. orcidid: 0000-0003-1460-5572 surname: McMahon fullname: McMahon, James H. email: james.mcmahon@monash.edu organization: Department of Infectious Diseases, Alfred Hospital and Monash University, Department of Infectious Diseases, Monash Medical Centre – sequence: 2 givenname: Jillian S. Y. surname: Lau fullname: Lau, Jillian S. Y. organization: Department of Infectious Diseases, Alfred Hospital and Monash University, Department of Infectious Diseases, Eastern Health – sequence: 3 givenname: Janine surname: Roney fullname: Roney, Janine organization: Department of Infectious Diseases, Alfred Hospital and Monash University – sequence: 4 givenname: Benjamin A. surname: Rogers fullname: Rogers, Benjamin A. organization: Department of Infectious Diseases, Monash Medical Centre – sequence: 5 givenname: Jason surname: Trubiano fullname: Trubiano, Jason organization: Department of Infectious Diseases, Austin Hospital – sequence: 6 givenname: Joseph surname: Sasadeusz fullname: Sasadeusz, Joseph organization: Department of Infectious Diseases, Royal Melbourne Hospital – sequence: 7 givenname: James S. surname: Molton fullname: Molton, James S. organization: Department of Infectious Diseases, Western Health – sequence: 8 givenname: Bradley surname: Gardiner fullname: Gardiner, Bradley organization: Department of Infectious Diseases, Alfred Hospital and Monash University, Epworth Healthcare – sequence: 9 givenname: Sue J. surname: Lee fullname: Lee, Sue J. organization: Department of Infectious Diseases, Alfred Hospital and Monash University – sequence: 10 givenname: Jennifer F. surname: Hoy fullname: Hoy, Jennifer F. organization: Department of Infectious Diseases, Alfred Hospital and Monash University – sequence: 11 givenname: Allen surname: Cheng fullname: Cheng, Allen organization: Department of Infectious Diseases, Alfred Hospital and Monash University – sequence: 12 givenname: Anton Y. surname: Peleg fullname: Peleg, Anton Y. organization: Department of Infectious Diseases, Alfred Hospital and Monash University |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33050947$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1177_20499361211063016 crossref_primary_10_1016_j_cct_2021_106625 crossref_primary_10_1128_AAC_02489_20 |
| ContentType | Journal Article |
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| DOI | 10.1186/s13063-020-04766-5 |
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| Discipline | Medicine |
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| Keywords | COVID-19 treatment adaptive protocol Randomised controlled trial community favipiravir |
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Primary objective:
To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of... Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation... Objectives Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of... ObjectivesPrimary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of... Abstract Objectives Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14... |
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| SubjectTerms | Amides - adverse effects Amides - therapeutic use Antiviral agents Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Australia - epidemiology Betacoronavirus - drug effects Betacoronavirus - genetics Biomarkers - metabolism Biomedicine Clinical Protocols community Coronavirus Infections - drug therapy Coronavirus Infections - epidemiology Coronavirus Infections - virology Coronaviruses COVID-19 COVID-19 study protocols Drug therapy favipiravir Female Health Sciences Hospitalization - statistics & numerical data Humans Letter Male Medicine Medicine & Public Health Pandemics Placebos Placebos - administration & dosage Pneumonia, Viral - drug therapy Pneumonia, Viral - epidemiology Pneumonia, Viral - virology protocol Pyrazines - adverse effects Pyrazines - therapeutic use Randomised controlled trial Safety SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Statistics for Life Sciences Testing treatment Treatment Outcome |
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