CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Favipiravir PlaceboWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (11)


Name (Synonyms) Correlation
drug1365 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.71
drug1569 Liberase Enzyme (Roche) Wiki 0.71
drug631 Centricyte 1000 Wiki 0.71
drug1746 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.71
drug2743 Sterile Normal Saline for Intravenous Use Wiki 0.71
drug1600 Lopinavir/ Ritonavir Placebo Wiki 0.71
drug1598 Lopinavir/ Ritonavir Wiki 0.71
drug1087 Favipiravir Wiki 0.32
drug2161 Placebo oral tablet Wiki 0.13
drug313 Azithromycin Wiki 0.12
drug1284 Hydroxychloroquine Wiki 0.07

Correlated MeSH Terms (11)


Name (Synonyms) Correlation
D011649 Pulmonary Alveolar Proteinosis NIH 0.71
D054990 Idiopathic Pulmonary Fibrosis NIH 0.71
D011658 Pulmonary Fibrosis NIH 0.27
D017563 Lung Diseases, Interstitial NIH 0.20
D008171 Lung Diseases, NIH 0.17
D003141 Communicable Diseases NIH 0.11
D011024 Pneumonia, Viral NIH 0.09
D014777 Virus Diseases NIH 0.08
D007239 Infection NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.71
HP:0002206 Pulmonary fibrosis HPO 0.27
HP:0006515 Interstitial pneumonitis HPO 0.20
HP:0002088 Abnormal lung morphology HPO 0.17

There are 2 clinical trials

Clinical Trials


1 Control of COVID-19 Outbreaks in Long Term Care (CONTROL-COVID)

To address the need to intervene to prevent the spread of COVID-19 in long-term care homes, we propose a randomized clinical trial of chemoprophylaxis in long-term care homes experiencing COVID-19 outbreaks. LTCH units experiencing an outbreak of COVID-19 will be randomized to chemoprophylaxis with favipiravir or placebo in a 1:1 ratio. Chemoprophylaxis in this setting refers to the use of favipiravir for pre-exposure prophylaxis, post-exposure prophylaxis, pre-emptive therapy, or treatment for established COVID-19. This design mimics the approach to influenza outbreaks, which has proven efficacy for outbreak control. The primary outcome will be control of the outbreak, defined as no new microbiologically confirmed case of COVID-19 for 24 consecutive days up to day 40.

NCT04448119 COVID-19 SARS-CoV-2 Drug: Favipiravir Drug: Favipiravir Placebo

Primary Outcomes

Description: Control of outbreak, defined as no new cases of COVID-19 in residents for 24 consecutive days up to day 40 after the start of prophylaxis

Measure: Control of Outbreak

Time: Day 40

Secondary Outcomes

Description: The proportion of residents of included LTCH units who die up to day 40, and up to day 60

Measure: Mortality (Residents)

Time: Day 40, Day 60

Description: The proportion of residents of included LTCH units who were uninfected at baseline and develop new symptomatic microbiologically confirmed COVID-19 up to day 40

Measure: COVID-19 Infection (Residents)

Time: Day 40

Description: The proportion of exposed staff uninfected at baseline in whom SARS-CoV-2 infection is identified up to day 14 and up to day 40

Measure: COVID-19 Infection (Staff)

Time: Day 14, Day 40

Description: The proportion of residents of included LTCH units hospitalized up to day 40

Measure: Hospitalization (Residents)

Time: Day 40

Description: The proportion of residents of included LTCH units who discontinue study medication due to adverse events

Measure: Medication Discontinuation (Residents)

Time: Day 40

Description: The proportion of LTCH staff of included LTCH units who discontinue study medication due to adverse events

Measure: Medication Discontinuation (Staff)

Time: Day 40

Description: The occurrence of new microbiologically confirmed COVID-19 infections in residents in other units of the LTCH up to day 40 (dichotomous, at LTCH level)

Measure: COVID-19 in new LTCH Units (a)

Time: Day 40

Description: The proportion of previously unaffected LTCH units of the remainder of the LTCH in which a case of COVID-19 is identified

Measure: COVID-19 in new LTCH Units (b)

Time: Day 40

Description: The proportion of residents in the remainder of the LTCH who develop COVID-19 infections up to day 40

Measure: COVID-19 in new LTCH Units (c)

Time: Day 40

2 Favipiravir, Lopinavir/Ritonavir or Combination Therapy: a Randomised, Double Blind, 2x2 Factorial Placebo-controlled Trial of Early Antiviral Therapy in COVID-19

The current pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with better outcome. The trial will be conducted in key workers who are at high risk of acquiring SARS-CoV-2 infection and their household members. Apart from the risk of severe illness and death in the workers themselves and their household members, this phenomenon also impacts health system staffing levels. The objective of the FLARE trial is to assess whether early antiviral therapy with either favipiravir + Lopinavir/ritonavir (LPV/r), LPV/r or favipiravir is associated with a decrease in viral load compared with placebo.The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease.

NCT04499677 COVID-19 Drug: Favipiravir Drug: Lopinavir/ Ritonavir Other: Favipiravir Placebo Other: Lopinavir/ Ritonavir Placebo

Primary Outcomes

Description: Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy

Measure: Upper respiratory tract viral load at Day 5

Time: Day 5 from randomisation

Secondary Outcomes

Description: Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy

Measure: Percentage of participants with undetectable upper respiratory tract viral load after 5 days of therapy

Time: 5 days from randomisation

Description: Quantitative polymerase chain reaction (PCR) performed on stool samples at Day 7 and Day 14 post-randomisation

Measure: Proportion of participants with undetectable stool viral load after 7 days of therapy and 14 days post-randomisation

Time: Day 7 and Day 14 from randomisation

Description: PCR performed on daily saliva samples collected between Day 1 and Day 7 post-randomisation

Measure: Rate of decrease in upper respiratory tract viral load during 7 days of therapy

Time: 7 days

Description: Daily body temperature records between Day 1 and Day 7 post-randomisation

Measure: Duration of fever following commencement of medication

Time: 7 days

Description: Standard diagnostic laboratory assays for liver transaminases, alkaline phosphatase and bilirubin

Measure: Proportion of participants with hepatotoxicity after 7 days of therapy and 14 days post-randomisation

Time: Day 7 and Day 14 from randomisation

Description: Determination of medication-related adverse events by investigators at Day 7 and Day 14 post-randomisation

Measure: Proportion of participants with other medication-related toxicity after 7 days of therapy and 14 days post-randomisation

Time: Day 7 and Day 14 from randomisation

Description: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation

Measure: Proportion of participants admitted to hospital with COVID-19 related illness

Time: 28 days

Description: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation

Measure: Proportion of participants admitted to ICU with COVID-19 related illness

Time: 28 days

Description: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation

Measure: Proportion of participants who have died with COVID-19 related illness

Time: 28 days

Description: Assess pharmacokinetics of favipiravir as measured by Clearance (CL)

Measure: Pharmacokinetics of favipiravir as measured by Clearance (CL)

Time: Day 7 from randomisation

Description: Assess pharmacokinetics of favipiravir as measured by Volume of distribution (V)

Measure: Pharmacokinetics of favipiravir as measured by Volume of distribution (V)

Time: Day 7 from randomisation

Description: Assess pharmacokinetics of favipiravir as measured by Absorption rate constant (Ka)

Measure: Pharmacokinetics of favipiravir as measured by Absorption rate constant (Ka)

Time: Day 7 from randomisation

Description: Assess pharmacokinetics of favipiravir as measured by Maximum concentration (Cmax)

Measure: Pharmacokinetics of favipiravir as measured by Maximum concentration (Cmax)

Time: Day 7 from randomisation

Description: Assess pharmacokinetics of favipiravir as measured by Time to maximum concentration (Tmax)

Measure: Pharmacokinetics of favipiravir as measured by Time to maximum concentration (Tmax)

Time: Day 7 from randomisation

Description: Assess pharmacokinetics of favipiravir as measured by Elimination rate constant (Ke)

Measure: Pharmacokinetics of favipiravir as measured by Elimination rate constant (Ke)

Time: Day 7 from randomisation

Description: Assess pharmacokinetics of favipiravir as measured by Area Under the Curve extrapolated to infinity (AUC (0-inf)

Measure: Pharmacokinetics of favipiravir as measured by Area Under the Curve extrapolated to infinity (AUC (0-inf)

Time: Day 7 from randomisation

Description: Assess pharmacodynamics of favipiravir as measured by Rate of viral load decline (delta)

Measure: Pharmacodynamics of favipiravir as measured by Rate of viral load decline (delta)

Time: Day 7 from randomisation

Description: Assess pharmacodynamics of favipiravir as measured by Maximum increase in viral load under drug treatment (Emax)

Measure: Pharmacodynamics of favipiravir as measured by Maximum increase in viral load under drug treatment (Emax)

Time: Day 7 from randomisation

Description: Assess pharmacodynamics of favipiravir as measured by Concentration to achieve half the maximum possible effect (EC50)

Measure: Pharmacodynamics of favipiravir as measured by Concentration to achieve half the maximum possible effect (EC50)

Time: Day 7 from randomisation

Description: Deep sequencing of virus and bioinformatic analysis

Measure: Proportion of participants with deleterious or resistance-conferring mutations in SARS-CoV-2 by Day 7 of treatment

Time: Day 7 from randomisation


No related HPO nodes (Using clinical trials)