Philippine Trial to Determine Efficacy and Safety of Favipiravir for COVID-19

NCT05014373 | Unknown Phase 3 DMC

• 1 other identifier: SJREB 2020-34
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Time from initiation of treatment to clinical improvement

  The duration from start of treatment (Favipiravir + Standard of care compared to Standard of care) to clinical improvement and maintained for at least 48 hours. Criteria for clinical improvement include all three must be reached: Body temperature: axillary ≤37.4°C Oxygen saturation measured by pulse oximeter of \>96% without oxygen inhalation Chest imaging findings with changes showing improvement

  4 to 28 days

Secondary Outcomes (4)

• Clinical effect of Favipiravir + Standard of Care compared to Standard of Care on patient status as measured by 7-point scale

  4 to 14 days of therapy

• Number of participants with conversion to negative level of SARS-COV2 viral genome

  4 to 14 days of therapy

• Number of participants with Changes in NEWS (National Early Warning Score)

  4 to 14 days of therapy

• Number of participants with improvement in chest imaging findings

  4 to 14 days of therapy

Study Arms (2)

Experimental: Favipiravir + Best supportive Care

ACTIVE COMPARATOR

Favipiravir (or Avigan) 1800 mg tablet 2x a day on Day 1 then 800 mg 2x a day from Day 2 to maximum of Day 14

Combination Product: Favipiravir + Standard of Care; Procedure: Standard of Care

Comparator: Best Supportive Care

PLACEBO COMPARATOR

Best supportive care or Standard Treatment includes oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs \& the medication any patient is on due to any concomitant diseases

Combination Product: Favipiravir + Standard of Care; Procedure: Standard of Care

Interventions

Favipiravir + Standard of Care COMBINATION_PRODUCT

1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily Plus Standard of Care

Comparator: Best Supportive Care; Experimental: Favipiravir + Best supportive Care

Standard of Care PROCEDURE

Best supportive care includes Standard treatment included oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs \& the medication any patient is on due to any concomitant diseases.

Comparator: Best Supportive Care; Experimental: Favipiravir + Best supportive Care

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 74 years (at the time of informed consent)
• Gender: Male or female
• Patients with SARS-CoV-2-positive nasopharyngeal swab by RT-PCR test with non-severe presentation upon admission to clinical trial site hospitals or trial-supervised quarantine facilities or under trial -supervised home isolation;
• For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug;
• Patients who understand the contents of this study and can provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents

You may not qualify if:

• Patient has manifestation that meets case definition of Severe COVID-19: Adult with clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) plus one of the following: respiratory rate \> 30 breaths/min; severe respiratory distress; or SpO2 \< 90% on room air.
• Fever (37.5°C) more than 7 days after the onset of fever
• Patients with suspected concomitant bacterial infections (e.g. 1 ng/ml or higher procalcitonin, etc.) prior to initiation of study drug
• Patients with suspected concomitant fungal infections (e.g. 30 pg/ml or higher (1-3)-β-d-glucan, etc.) prior to initiation of study drug
• Patients with suspected concurrent congestive heart failure (e.g. 100 pg/mL or higher NT-pro BNP levels, etc.) prior to initiation of study drug
• Patients with severe hepatic impairment (\>Grade 3: ALT \>10 times of upper normal limit)
• Patients with renal impairment requiring dialysis
• Patients with disturbed consciousness such as disturbed orientation
• Pregnant or possibly pregnant patients
• Female patients who are unable to consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices during the 7 days after the start of favipiravir administration.
• Male patients whose partner cannot agree to use the contraception method described in (10) above
• Patients who cannot consent to the use of condoms from the start of favipiravir administration to 7 days after the end of favipiravir administration
• Patients with hereditary xanthinuria
• Patients who have previously ever been diagnosed with hypouricemia (\< 1 mg/dL) or xanthine urinary calculi
• Patients with a history of gout or on treatment for gout or hyperuricemia

Sponsors & Collaborators

• University of the Philippines: lead
• Department of Health, Philippines: collaborator

Study Sites (1)

Dr. Regina Berba

Manila, National Capital Region, 1000, Philippines

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Regina. Berba., MD

  Philippine General Hospital, Manila Philippines

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Berba, MD

CONTACT

+639985381599; rpberba@gmail.com

Regina Berba., MD

CONTACT

+639985381599; rpberba@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: August 20, 2021
• Study Start: October 12, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

PH (1)