Covid 19 Research using Clinical Trials (Home Page)
FavipiravirWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (34)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1611 | non interventional Wiki | 0.30 |
| drug1479 | Vitamins Wiki | 0.30 |
| drug297 | Centricyte 1000 Wiki | 0.30 |
| drug511 | Favipiravir Combined With Tocilizumab Wiki | 0.30 |
| drug985 | Pathogen-specific aAPC Wiki | 0.30 |
| drug1291 | Standard of care treatment Wiki | 0.30 |
| drug1288 | Standard of care management Wiki | 0.30 |
| drug651 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.30 |
| drug953 | Other drugs Wiki | 0.30 |
| drug825 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.30 |
| drug941 | Only Standard Treatment Wiki | 0.30 |
| drug1310 | Sterile Normal Saline for Intravenous Use Wiki | 0.30 |
| drug744 | Liberase Enzyme (Roche) Wiki | 0.30 |
| drug662 | Imatinib Wiki | 0.21 |
| drug1507 | Zinc Sulfate Wiki | 0.21 |
| drug1170 | Routine care for COVID-19 patients Wiki | 0.21 |
| drug884 | Niclosamide Wiki | 0.21 |
| drug1367 | Telmisartan Wiki | 0.21 |
| drug686 | Interferon Beta-1B Wiki | 0.17 |
| drug749 | Lopinavir / Ritonavir Wiki | 0.17 |
| drug876 | Nasopharyngeal swab Wiki | 0.17 |
| drug685 | Interferon Beta-1A Wiki | 0.17 |
| drug591 | Hydroxychloroquine Wiki | 0.16 |
| drug889 | Nitazoxanide Wiki | 0.15 |
| drug280 | Camostat Mesilate Wiki | 0.15 |
| drug1035 | Placebo oral tablet Wiki | 0.12 |
| drug1172 | Ruxolitinib Wiki | 0.11 |
| drug129 | Azithromycin Wiki | 0.11 |
| drug715 | Ivermectin Wiki | 0.11 |
| drug308 | Chloroquine Wiki | 0.11 |
| drug1146 | Remdesivir Wiki | 0.08 |
| drug1042 | Placebos Wiki | 0.08 |
| drug1402 | Tocilizumab Wiki | 0.07 |
| drug1016 | Placebo Wiki | 0.02 |
Correlated MeSH Terms (15)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001416 | Back Pain NIH | 0.30 |
| D011649 | Pulmonary Alveolar Proteinosis NIH | 0.30 |
| D017116 | Low Back Pain NIH | 0.30 |
| D010146 | Pain NIH | 0.30 |
| D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.30 |
| D011565 | Psoriasis NIH | 0.30 |
| D003141 | Communicable Diseases NIH | 0.21 |
| D007239 | Infection NIH | 0.14 |
| D011658 | Pulmonary Fibrosis NIH | 0.13 |
| D017563 | Lung Diseases, Interstitial NIH | 0.12 |
| D018352 | Coronavirus Infections NIH | 0.12 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.12 |
| D014777 | Virus Diseases NIH | 0.12 |
| D008171 | Lung Diseases, NIH | 0.11 |
| D011024 | Pneumonia, Viral NIH | 0.04 |
Correlated HPO Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0003765 | Psoriasiform dermatitis HPO | 0.30 |
| HP:0006517 | Alveolar proteinosis HPO | 0.30 |
| HP:0002206 | Pulmonary fibrosis HPO | 0.17 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.13 |
| HP:0002088 | Abnormal lung morphology HPO | 0.12 |
There are 11 clinical trials
Clinical Trials
1 Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study
The purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.
NCT04310228 COVID-19 Drug: Favipiravir Combined With Tocilizumab Drug: Favipiravir Drug: Tocilizumab MeSH:Coronavirus Infections Virus Diseases
Primary Outcomes
Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 3 monthsSecondary Outcomes
Measure: Viral nucleic acid test negative conversion rate and days from positive to negative Time: 14 days after taking medicineMeasure: Duration of fever Time: 14 days after taking medicine
Measure: Lung imaging improvement time Time: 14 days after taking medicine
Measure: Mortality rate because of Corona Virus Disease 2019 Time: 3 months
Measure: Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs Time: 3 months
Measure: Mean in-hospital time Time: 3 months
2 The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.
NCT04333589 COVID-19 Drug: Favipiravir MeSH:Coronavirus Infections Virus Diseases
Primary Outcomes
Description: Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
Measure: Viral nucleic acid test negative conversion rate Time: 5 monthsSecondary Outcomes
Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 5 months3 A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating the Efficacy and Safety of Favipiravir in the Treatment of Patients With COVID-19-Moderate Type
This study evaluates treatment with Favipiravir combined with supportive care for adult patients with COVID-19-moderate type.
NCT04336904 COVID-19 Drug: Favipiravir Other: Placebo
Primary Outcomes
Description: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72 hours.
Measure: Time from randomization to clinical recovery Time: 90 daysSecondary Outcomes
Description: 1. Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization;
Measure: Time from randomization to negativity in RT-PCR nucleic acid test Time: 28 daysDescription: Incidence of deterioration/aggravation of pneumonia (defined as SPO2≤93% or PaO2/FiO2 ≤300 mmHg or distressed RR≥30/min without oxygen inhalation and requiring oxygen therapy or more advanced breath support) within 28 days of randomization;
Measure: Incidence of deterioration/aggravation of pneumonia Time: 28 daysDescription: Time from randomization to resolution of pyrexia (defined the same as for the primary efficacy variable; applicable to subjects with pyrexia at enrolment) within 28 days of randomization;
Measure: Time from randomization to resolution of pyrexia Time: 28 daysDescription: Time from randomization to relief of cough (defined the same as for the primary efficacy variable; applicable to subjects with cough at enrolment) within 28 days of randomization; It is recommended that the severity of cough be graded as per NCI-CTCAE v5.0: Mild: Requires non-prescription treatment; Moderate: Requires medication treatment; limits instrumental activities of daily living; Severe: Limits self-care activities of daily living
Measure: Time from randomization to relief of cough Time: 28 daysDescription: Time from randomization to relief of dyspnoea (defined as subject-perceived improvement or resolution of dyspnoea; applicable to subjects with dyspnoea at enrolment) within 28 days of randomization;
Measure: Time from randomization to relief of dyspnoea Time: 28 daysDescription: 6. Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization
Measure: Rate of auxiliary oxygen therapy Time: 28 daysDescription: ICU admission rate within 28 days of randomization
Measure: ICU admission rate Time: 28 daysDescription: All-cause mortality within 28 days of randomization
Measure: Mortality Time: 28 days4 The Results of COVID 19 Treatment: A Real-life Experience on Patients With COVID 19
COVID 19 treatment using Chloroquine with or without Azithromycin, Faviprevir, Nitazoxanide, Ivermectin.
NCT04345419 COVID Drug: Chloroquine Drug: Favipiravir Drug: Nitazoxanide Drug: Ivermectin Drug: Niclosamide Drug: Other drugs
Primary Outcomes
Description: the estimated number of patients with decreased viral load
Measure: Number of patients with decreased viral load Time: 6 months5 A Phase 2 Randomized, Open Label Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild COVID-19
The objective of this study is to evaluate the efficacy of oral favipiravir compared with SOC in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.
NCT04346628 COVID Drug: Favipiravir Other: Standard of care treatment
Primary Outcomes
Description: Time in days from randomization to a negative result of nasopharyngeal and/or oropharyngeal and/or salivary swab.
Measure: Time until cessation of oral shedding of SARS-CoV-2 virus Time: Up to 28 daysSecondary Outcomes
Description: Clinical worsening will be determined by clinician assessment.
Measure: Count of participants with clinical worsening of COVID-19 disease Time: Up to 28 daysDescription: Viral load will be assessed as the TCID50 (Median Tissue Culture Infectious Dose) over time.
Measure: Sars-CoV-2 viral load Time: Up to 28 daysMeasure: Count of participants with development of SARS-CoV-2 antibodies Time: Up to 28 days
Measure: Time until cessation of symptoms Time: Up to 28 days
Description: Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.
Measure: Cmax of favipiravir Time: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)Description: Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.
Measure: Cmin of favipiravir Time: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)6 Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment
Faviprevir in COVID-19 treatment
NCT04351295 COVID Drug: Favipiravir Drug: Placebos
Primary Outcomes
Description: The total number of patients with viral cure
Measure: Number of patients with viral cure Time: 6 months7 Outpatient Treatment of Elderly People With Symptomatic SARS-CoV-2 Infection (COVID-19): a Multi-arm, Multi-stage (MAMS) Randomized Trial to Assess the Efficacy and Safety of Several Experimental Treatments to Decrease the Risk of Hospitalization or Death (COVERAGE Trial)
This trial will estimate the efficacy and tolerance of several experimental treatments to prevent hospitalization or death in outpatients aged 65 years or above with Symptomatic SARS-CoV-2 Infection (COVID-19).
NCT04356495 Corona Virus Infection Sars-CoV2 Dietary Supplement: Vitamins Drug: Hydroxychloroquine Drug: Imatinib Drug: Favipiravir Drug: Telmisartan MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Measure: Proportion of participants with an occurrence of hospitalization Time: From inclusion (day0) to day 14Description: Proportion of participants with an occurrence of death
Measure: Death Time: From inclusion (day0) to day 14Secondary Outcomes
Measure: Proportion of hospitalizations, overall and by cause, in each group Time: From inclusion (day0) to day 28Description: Proportion of deaths, overall and by cause, in each group
Measure: Death and causes of death Time: From inclusion (day0) to day 28Measure: Proportion of intensive care hospitalizations, overall and by cause, in each group Time: From inclusion (day0) to day 28
Measure: Proportion of participants with negative nasopharyngeal SARS-CoV-2 RT-PCR Time: day 7 and day 14
Measure: Proportion of participants with a loss of autonomy evaluated by the ADL and IADL scale Time: day 14 and day 28
Description: Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR
Measure: Haematological markers evolution Time: from inclusion (day 0) to day 7 and day 14Description: Evolution of Biochemical markers in each group : ferritin, serum creatinine, urea, sodium, potassium, chlorine, calcium, magnesium, albumin, bicarbonates / tCO2, LDH, CPK, ASAT, ALAT, uricemia
Measure: Biochemical markers evolution Time: from inclusion (day 0) to day 7 and day 14Description: Evolution of Inflammatory markers in each group : PCT, CRP
Measure: Inflammatory markers evolution Time: from inclusion (day 0) to day 7 and day 14Description: Evolution of immunological markers in each group : B ans T Cells phenotypic profiles
Measure: Immunological markers evolution Time: from inclusion (day 0) to day 7 and day 14Description: Number and proportion of grade 1,2,3,4 adverse events in each group
Measure: Adverse events Time: from inclusion (day 0) to day 14Description: Number and proportion of grade 1,2,3,4 adverse events in each group
Measure: Adverse reactions Time: from inclusion (day 0) to day 14Description: Plasma concentration of the study drugs at D7
Measure: Plasma concentration Time: day 7Description: Acceptability of the treatment by participant will be assessed with an interview
Measure: Acceptability of the treatment Time: from inclusion (day 0) to day 108 Efficacy and Safety of Favipiravir Compared to the Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial
The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04359615 COVID-19 Drug: Favipiravir Drug: Hydroxychloroquine
Primary Outcomes
Description: Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
Measure: Time to clinical improvement Time: From date of randomization until 14 days later.Secondary Outcomes
Description: If the patient dies, we have reached an outcome.
Measure: Mortality Time: From date of randomization until 14 days later.Description: Pulse-oxymetry
Measure: oxygen saturation by pulse oximetry (SpO2) Improvement Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.Description: Incidence of new mechanical ventilation use
Measure: Incidence of new mechanical ventilation use Time: From date of randomization until 14 days later.Description: Duration of hospitalization (days)
Measure: Duration of hospitalization Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.Description: With incidence of any serious adverse effects, the outcome has happened.
Measure: Cumulative incidence of serious adverse events Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.9 A Randomised Controlled Trial of Early Intervention in Patients HospItalised With COVID-19: Favipiravir Verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe
Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either a combination of azithromycin, hydroxychloroquine and zinc or favipiravir, alongside usual care, can help patients with suspected or proven COVID-19 infection.
NCT04373733 Coronavirus Infection Drug: Favipiravir Drug: Hydroxychloroquine Drug: Azithromycin Drug: Zinc Sulfate Other: Standard of care management MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Time from randomisation to clinical improvement by two points on a seven-category ordinal scale: Not hospitalised with resumption of normal activities Not hospitalised, but unable to resume normal Hospitalised, not requiring supplemental oxygen Hospitalised, requiring supplemental oxygen Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both Death
Measure: Time to improvement by two points on a seven-category ordinal scale Time: Up to 28 days from randomisationSecondary Outcomes
Description: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
Measure: Clinical status on a seven-category ordinal scale (Day 7) Time: Day 7 from randomisationDescription: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
Measure: Clinical status on a seven-category ordinal scale (Day 14) Time: Day 14 from randomisationDescription: Survival of patients to end of study
Measure: Overall survival Time: 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS score of patient condition, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS score Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for temperature, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for temperature Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for heartrate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for heartrate Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for respiratory rate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for respiratory rate Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for oxygen saturation, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for oxygen saturation. Time: Up to 28 days from randomisationDescription: Frequency of admission of patients to intensive care
Measure: Admission to intensive care Time: Up to 28 days from randomisationDescription: Frequency of requirement to administer mechanical ventilation to patients
Measure: Requirement for mechanical ventilation Time: Up to 28 days from randomisationDescription: Frequency of requirement to administer non-invasive ventilation, continuous positive airways pressure or high-flow oxygen to patients
Measure: Requirement for non-invasive ventilation, continuous positive airways pressure or high-flow oxygen Time: Up to 28 days from randomisationDescription: Frequency of culture-confirmed bacterial or fungal infection in patients
Measure: Incidence of bacterial or fungal infection Time: Up to 28 days from randomisationDescription: Frequency and severity of adverse events in patients not directly attributed by clinicians to COVID-19 infection.
Measure: Incidence of adverse events not directly caused by COVID-19 infection. Time: Up to 28 days from randomisation.Other Outcomes
Description: Frequency of readmission to inpatient care of patients discharged from hospital.
Measure: Readmission to inpatient care Time: Up to 28 days from randomisation10 Treatment of Covid-19 With Favipiravir Versus Hydroxychloroquine: a Randomized Comparator Trial
Hydroxychloroquine is widely used to treat autoimmune diseases. Clinical investigation has found that a high concentration of cytokines were detected in the plasma of critically ill patients infected with SARS-CoV-2, therefore, hydroxychloroquine as anti-inflammatory agents may reduce this response in accord with their use in autoimmune disease where the cytokine response can be reduced. Favipiravir is an antiviral drug developed in Japan that the data sheet notes that it is a pyrazinecarboxamide derivative with activity against influenza viruses, west nile virus, yellow fever virus, foot and mouth disease virus as well as against flaviviruses, arenaviruses, bunyaviruses and alphaviruses. In February the drug was used for COVID-19 disease in China and was declared effective in treatment, and a report published (in press) comparing Favipiravir with Lopinavir /ritonavir suggested that Favipiravir was superior for prevention of disease progression and viral clearance. The objective of this pilot study is to compare 3 arms: hydroxychloroquine; favipiravir; supportive treatment only, in symptomatic patients infected by SARS-CoV-2 in an open label randomized clinical trial. The difference between groups will allow an effect size to be determined for a definitive clinical trial
NCT04387760 SARS-CoV 2 COVID-19 Drug: Hydroxychloroquine Drug: Favipiravir Other: Routine care for COVID-19 patients
Primary Outcomes
Description: Two consecutive negative (SARS-CoV-2 PCR) nasopharyngeal swabs
Measure: Primary outcome measure will be time to viral clearance Time: through study completion up to 21 daysSecondary Outcomes
Description: Implementation of escalation of Respiratory Support
Measure: Requirement of Escalation of Respiratory Support Time: through study completion up to 21 daysDescription: Time frame for presenting symptoms to resolve
Measure: Time until resolution of presenting symptoms Time: through study completion up to 21 daysDescription: Monitor and document all adverse effects during therapy
Measure: Adverse effects Time: through study completion up to 21 daysDescription: Deterioration of clinical condition requiring ICU admission
Measure: Requirement of ICU Admission Time: through study completion up to 21 daysDescription: Mortality rate due to COVID-19
Measure: Mortality rate Time: Mortality will be collected at 28 daysDescription: Determination of the change in lactate levels before and after treatment as a measure of disease activity
Measure: Serum lactate measurement Time: through study completion up to 21 daysDescription: Determination of the change in ferritin levels before and after treatments as a measure of disease activity
Measure: Serum Ferritin measurement Time: through study completion up to 21 daysDescription: Determination of the change in D Dimer levels before and after treatments as a measure of disease activity
Measure: Serum D Dimer measurement Time: through study completion up to 21 daysDescription: Determination of the change in procalcitonin levels before and after treatments as a measure of disease activity
Measure: Serum procalcitonin measurement Time: through study completion up to 21 daysDescription: Determination of the change in brain naturetic peptide levels before and after treatments as a measure of disease activity
Measure: Serum brain naturetic peptide measurement Time: through study completion up to 21 daysDescription: Determination of the change in Ratio of Lymphocyte to Neutrophil, before and after treatments as a measure of disease activity
Measure: Ratio of Lymphocyte to Neutrophil, measurement Time: through study completion up to 21 days11 Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh
A recent outbreak of coronavirus disease 2019 (COVID-19) caused by the novel coronavirus designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started in Wuhan, China, at the end of 2019. The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnea, and pneumonia. As of 25 February 2020, at least 77 785 cases and 2666 deaths had been identified across China and in other countries; in particular, 977 and 861 cases were identified in South Korea and Japan, respectively. The outbreak has already caused global alarm. On 30 January 2020, the World Health Organization (WHO) declared that the outbreak of SARS-CoV-2 constituted a Public Health Emergency of International Concern (PHEIC), and issued advice in the form of temporary recommendations under the International Health Regulations (IHR).It has been revealed that SARS-CoV-2 has a genome sequence that is 75%-80% identical to that of SARS-CoV, and has more similarities to several bat coronaviruses. SARS-CoV-2 is the seventh reported human-infecting member of the family Coronaviridae, which also includes SARS-CoV and the Middle East respiratory syndrome (MERS)-CoV. It has been identified as the causative agent of COVID-19. Both the clinical and the epidemiological features of COVID-19 patients demonstrate that SARS-CoV-2 infection can lead to intensive care unit (ICU) admission and high mortality. About 16%-21% of people with the virus in China have become severely ill, with a 2%-3% mortality rate. However, there is no specific treatment against the new virus. Therefore, it is urgently necessary to identify effective antiviral agents to combat the disease and explore the clinical effect of antiviral drugs. One efficient approach to discover effective drugs is to test whether the existing antiviral drugs are effective in treating other related viral infections. Several drugs, such as ribavirin, interferon (IFN), Favipiravir (FPV), and Lopinavir (LPV)/ritonavir (RTV), have been used in patients with SARS or MERS, although the efficacy of some drugs remains controversial. It has recently been demonstrated that, as a prodrug, Favipiravir (half maximal effective concentration (EC50) = 61.88 μmol·L−1, half-maximal cytotoxic concentration (CC50) > 400 μmol·L−1, selectivity index (SI) > 6.46) effectively inhibits the SARS-CoV-2 infection in Vero E6 cells (ATCC-1586). Furthermore, other reports show that FPV is effective in protecting mice against Ebola virus challenge, although its EC50 value in Vero E6 cells was as high as 67 μmol·L−1. Therefore, clinical studies are urgently needed to evaluate the efficacy and safety of this antiviral nucleoside for COVID-19 treatment. After enrollment of the patients (day 1) depending on inclusion and exclusion criteria and laboratory findings confirming the presence of the COVID-19 virus, 25 patients will receive Favipiravir plus standard treatment and the second group of 25 patients will receive standard treatment only. The comparison of the findings of the follow up studies on days 4, 7, and 10 in terms of clinical manifestations, chest X-ray and laboratory findings, such as Real Time Polymerase Chain Reaction (RT-PCR) results for viral presence will determine whether Favipiravir has safety and efficacy against COVID-19 infections. All ethical issues related to this trial including right of the participants to withdraw from the study should be maintained according to of guidelines of International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).
NCT04402203 COVID-19 Favipiravir (Favipira) Drug: Favipiravir Drug: Only Standard Treatment
Primary Outcomes
Description: Negative by RT-PCR for the virus at 4-10 days after initiation of therapy. However, negative results for the viral presence should be with an interval of at least 24 hours.
Measure: Number of participants negative by RT-PCR for the virus at 4-10 days after initiation of therapy. Time: at 4 to 10 days of therapyDescription: X-ray findings of lung condition improvement at Day-4, Day-7 and Day-10 of therapy
Measure: Number of participants with lung condition change assessed with X-ray. Time: at Day-4, Day-7 and Day-10 of therapySecondary Outcomes
Description: Clinical recovery indicates reduced duration of fever, cough, relief time auxiliary oxygen therapy or noninvasive mechanical ventilation rate.
Measure: Number of participants with clinical recovery Time: at Day-4, Day-7 and Day-10 of therapyMeasure: Number of participants with adverse effects of drug. Time: at Day-4, Day-7 and Day-10 of therapy
Measure: Number of participants requiring ICU admission Time: at Day-4, Day-7 and Day-10 of therapy
Measure: Number of death Time: at Day-4, Day-7 and Day-10 of therapy