Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19

NCT ID: NCT04346628

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-12
• Study Completion Date: 2021-04-16

Brief Summary

The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.

Conditions

Sars-CoV2; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Favipiravir

In addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28.

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

Favipiravir administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).

Standard of care treatment

Intervention Type: OTHER

Standard of care treatment for COVID-19 infection

Placebo

In addition to SOC, participants will receive placebo to match favipiravir for 10 days, and be evaluated for health outcomes through day 28.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match favipiravir administered orally through day 10.

Standard of care treatment

Intervention Type: OTHER

Standard of care treatment for COVID-19 infection

Interventions

Favipiravir

Favipiravir administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).

Intervention Type: DRUG

Placebo

Placebo to match favipiravir administered orally through day 10.

Intervention Type: DRUG

Standard of care treatment

Standard of care treatment for COVID-19 infection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of COVID-19 disease:

• If symptomatic, presence of mild to moderate symptoms without signs of respiratory distress, with positive for SARS-CoV-2 diagnostic assay within 72 hours prior to.informed consent.
• If asymptomatic, initial diagnosis obtained no more than 72 hours prior to informed consent
• Subject agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol

Exclusion Criteria

• Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
• Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
• Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
• Females must have a negative pregnancy test at screening
• Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol

• Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).
• History of abnormal uric acid metabolism.
• History of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
• Abnormal laboratory test results at screening:
• Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.
• Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
• Previously received favipiravir within the past 30 days.
• Advanced kidney disease
• Advanced liver disease
• History of alcohol or drug abuse in the previous two years.
• Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
• Taken another investigational drug within the past 30 days.
• Seemed by the Investigator to be ineligible for any reason.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvonne (Bonnie) A Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

Holubar M, Subramanian A, Purington N, Hedlin H, Bunning B, Walter KS, Bonilla H, Boumis A, Chen M, Clinton K, Dewhurst L, Epstein C, Jagannathan P, Kaszynski RH, Panu L, Parsonnet J, Ponder EL, Quintero O, Sefton E, Singh U, Soberanis L, Truong H, Andrews JR, Desai M, Khosla C, Maldonado Y. Favipiravir for Treatment of Outpatients With Asymptomatic or Uncomplicated Coronavirus Disease 2019: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Clin Infect Dis. 2022 Nov 30;75(11):1883-1892. doi: 10.1093/cid/ciac312.

Reference Type: RESULT

PMID: 35446944 (View on PubMed)

Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.

Reference Type: DERIVED

PMID: 33624010 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

56032

Identifier Type: -

Identifier Source: org_study_id