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Study of Favipiravir DPI in SARS-CoV-2 Infection.

Proof of concept study to evaluate the safety and effectiveness of Favipiravir DPI as an intervention in subjects with SARS-CoV-2 Infection. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033750
Enrollment
60
Registered
2021-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Favipiravir DPI: Favipiravir DPI in 20 mg/ day dosage for 10 days Intervention2: Favipiravir DPI: Favipiravir DPI in 10 mg/ day dosage for 10 days Control Intervention1: Favipiravir ora

Sponsors

SAVA Healthcare Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age -18- 60 years (Both sex) 2.Confirmed COVID 19 patient with positive RT-PCR 3.Mild symptomatic or asymptomatic patients having no signs of severe disease (NEWS score 4.Subject willing to provide consent and follow up for study duration

Exclusion criteria

Exclusion criteria: 1.Patients with compromised immunity, autoimmune disease or self-reports HIV or syphilis infection 2.Proves to be unfit for the study as per the investigatorâ??s discretion 3.Pregnant or lactating women 4.Requiring supplemental oxygen and ICU admission at screening 5.Comorbidity at screening and which in investigator discretion finds subject not suitable for the trial participation

Design outcomes

Primary

MeasureTime frame
RT-PCR test for COVID 19- Day 5 and 10 Improvement of clinical symptoms including duration of respiratory distress, cough, sneezing and diarrhea Requirements of supplemental oxygen and SpO2 levels Reduction in elevated levels CRP, LDH, D-Dimer, Interleukin 6 and Ferritin Daily SpO2 levels from baseline to end of studyTimepoint: From baseline to day 10—

Secondary

MeasureTime frame
Changes in serum electrolyte levels- At screening and end of the study Changes in serum levels of liver enzymes such as SGPT and SGOT, creatinine- At screening and end of the study Requirement of admission to intensive care unit from baseline to end of study Duration of hospitalization from baseline to end of study Complete blood count, KFT, lipid profile at screening and end of the dayTimepoint: From baseline to day 10—

Countries

India

Contacts

Public ContactMr Avinaash Mandale

SAVA Healthcare Ltd

sriram.p@savaglobal.com7507003688

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026