Favipiravir Therapy in Adults With Mild COVID-19

COVID-19 Clinical Trial

— Avi-Mild  

Official title:

A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464408
• Other study ID #: RC 20/220/R
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 23, 2020
• Est. completion date: August 4, 2021

Study information

• Verified date: November 2021
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: August 4, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria

Patients must be eligible according to the following criteria for enrollment

1. Should be at least 18 years of age

2. Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it)

3. Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the time of recruitment, a result within the last five days

4. Patients have to be enrolled within 5 days of disease onset.

Exclusion criteria

Patients meeting any of the following criteria will be excluded from trial enrolment:

1. Patients with concomitant documented bacterial pneumonia established through positive sputum cultures

2. Patients who are pregnant or breastfeeding

3. Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza)

4. Major comorbidities increasing the risk of study drug including

• Hematologic malignancy

• Advanced (stage 4-5) chronic kidney disease or dialysis therapy

• Severe liver damage (Child-Pugh score C, AST> 5 times the upper limit)

• HIV

• Gout/history of Gout or hyperuricemia (two times above the ULN)

(6) Having used Favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission.

(9) Hospitalized patients for mild, moderate, or severe COVID-19

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Favipiravir
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
• Placebo
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)

Locations

Country	Name	City	State
Saudi Arabia	King Fahad Hospital - Madinah	Al Madinah
Saudi Arabia	Primary Health Care-Safiyah	Al Madinah
Saudi Arabia	Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah	Al Madinah
Saudi Arabia	King Abdullah Medical City - Makkah	Mecca
Saudi Arabia	King Abdulaziz Medical City - Riyadh	Riyadh
Saudi Arabia	Primary Health Care-Al Mansoura	Riyadh
Saudi Arabia	Primary Health Care-Al Urijah	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center	Ministry of Health, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR negative	Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization	15 days
Secondary	Time from randomization to clinical recovery	The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.	15 days
Secondary	Evaluate symptoms progression	Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.	28 days
Secondary	Evaluate Faviparivirs effect	To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.	15 days
Secondary	Evaluate Favipiravir's effect	To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )	28 days
Secondary	Evaluate the safety of Favipiravir	Evaluate the safety of investigational drug compared to the control arm within 15 days after starting the medicine. This is assessed by allergic reactions, medication intolerance, liver toxicity, and hyperuricemia in subjects	28 days