A clinical study on Favipiravir in mild to moderate COVID-19 patients

Not Applicable

Completed

Brief Summary: This is a prospective, open label, multicenter, single arm, post marketing study for evaluation of safety and efficacy ofFavipiravir in Adult Indian Patients with Mild to Moderate COVID-19 disease. Primary objective of the study is to evaluate safety and secondary objective is to evaluate efficacy of Favipiravir in mild to moderate cases of COVID-19. 1200 adult patients will be enrolled in the study. The anticipated maximum total study duration foreach patient is approximately 30 days (maximum) which includes screening of up to 2 days, enrolment of 1 day, actualtreatment period as per treating physicianâ€™s prescription (up to 14 daysmaximum), and an on-site/centre follow-up visit/telephonic follow-up aftercompletion of treatment which would be a routine follow up visit per normalclinical practice.

Recruitment & Eligibility

Inclusion Criteria

Adult patients aged 18 years and above with mild to moderate COVID-19.
Patients who receive a prescription of favipiravir according to the indication stated in the approved prescribing information in India 3.
Pyrexia (defined as axillary temperature more than or equal to 99 F or oral temperature more than or equal to 100 F) AND at least one of the following: Cough, fatigue, dyspnoea, expectoration, myalgia, rhinorrhoea, sore throat, diarrhoea, new loss of taste or smell, myalgia, headache or fatigue on admission.
Respiratory rate less than or equal to 30/min.
SpO2 more than or equal to 90% on room air.
Agree to follow effective contraceptive methods during and for 7 days after the end of the treatment with favipiravir for male and female patients in the reproductive age group.
For female patients of child-bearing age: evidence of negative pre-treatment urine pregnancy test 8.
Voluntarily participating in the study; fully understanding and being fully informed of the study and having signed written Informed Consent Form (ICF).

Exclusion Criteria

Refusal to participation expressed by patient or legally authorized representative.
Requiring NIV, Mechanical Ventilation or ECMO at baseline.
Severe hepatic or renal impairment 4.
Pregnant or lactating women.
History of known hypersensitivity to Favipiravir.
Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure) 7.
Patients who have participated in any clinical trial within 30 days prior to enrolment and would not be participating in clinical study during the period of study participation.
Any other COVID-19 antiviral treatment.

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of favipiravir prescribed in treatment of patients with mild to moderate COVID-19 disease in India.	Upto 28 days
3. Number of treatment related AEs and SAEs as assessed by the treating physician	Upto 28 days
1. Number of AEs	Upto 28 days
2. Number of SAEs	Upto 28 days
4. Number of AEs leading to dose modification/ discontinuation of treatment	Upto 28 days

Secondary Outcome Measures

Name	Time	Method
1. Time to clinical cure	Defined as resolution of baseline clinical signs and symptoms of COVID-19 infection based on clinical assessment by the investigator.

Locations (14): Aster Prime Hospital
🇮🇳
Hyderabad, TELANGANA, India
Care Hospital
🇮🇳
Hyderabad, TELANGANA, India
Dr Vasantrao Pawar Medical College, Hospital and Research Center
🇮🇳
Nashik, MAHARASHTRA, India
Government Medical College and Hospital
🇮🇳
Nagpur, MAHARASHTRA, India
KEM Hospital Research Center
🇮🇳
Pune, MAHARASHTRA, India
Lokmanya Tilak Muncipal Medical College and General Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
N Medical College and B.Y.L Nair Ch. Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
NIMS, Thiruvananthapuram
🇮🇳
Thiruvananthapuram, KERALA, India
Renova Neelima Hospital
🇮🇳
Hyderabad, TELANGANA, India
Seth GS Medical College and KEM Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Scroll for more (4 remaining)
Aster Prime Hospital
🇮🇳Hyderabad, TELANGANA, India
Dr Nagaraju Boyilla
Principal investigator
9848883444
nagaraj.boyilla@gmail.com