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A clinical study to evaluate the efficacy and safety of Sofosbuvir/Daclatasvir (tablet) with or without Nitazoxanide when given with the standard of care in Moderate COVID-19 Patients.

Phase IIb Study to Evaluate the Efficacy and Safety of Sofosbuvir/Daclatasvir (Sof/Dcv) With or Without Nitazoxanide In Combination with Standard of Care in Adult Patients with Moderate Covid-19

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030013
Enrollment
366
Registered
2020-12-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination: Arm 1- MyHep DVIRTM
(Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination) once daily for 14 days + SOC. Intervention2: Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combi
(Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination)+ 500 mg of Nitazoxanide twice daily for 14 days in addition to SOC Intervention3: Daclatasvir and Sofosbuvir Film Coat

Sponsors

Mylan Laboratories Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female, age � 18 to � 65 years 2.Subject (or legally authorized representative) provides informed consent prior to initiation and comply with planned study procedures. 3.Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) 4.Illness of Moderate severity

Exclusion criteria

Exclusion criteria: 1.Patients with clinical signs of pneumonia plus signs of severe Covid. 2.Requiring mechanical ventilation or ECMO at screening 3.Estimated glomerular filtration rate (eGFR) 4.Cardiac failure NYHA Class III, IV and V. 5.Pregnancy or breast feeding. 6.Evidence of multiorgan failure 7.Any malignancy or cerebro-vascular complications 8.Any other condition as per the physicianââ?¬•s discretion which would make the patient unsuitable for enrollment in the study

Design outcomes

Primary

MeasureTime frame
1.SARS CoV-2 Viral Negativity Rate 2.Time to Clinical ImprovementTimepoint: 1.At day 7 2.At day 15—

Secondary

MeasureTime frame
1.Percentage of subjects reporting each severity rating on an 8-point ordinal scale 2.Change from baseline in National Early Warning Score (NEWS) 3.Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs)/SAEs- Mortality 4.Incidence of rescue medication use- SARS-CoV2 negativityTimepoint: 1.At days 3,5,8,11,15 and 29 2.At days 3,8 and 15 3.At day 29 4.At day 10 and 14—

Countries

India

Contacts

Public ContactDr Jayashri Krishnan

JSS Medical Research Asia Pacific Private Limited

sonika.newar@jssresearch.com08698065660

Outcome results

None listed

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