A Clinical trial to evaluate the effect of a combination of treatment of Reginmune capsule and Immunofree tablets in the treatment of mild to moderate COVID-19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/08/026957
- Lead Sponsor
- Corival Lifesciences Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive).
2. Patients with RT-PCR confirmed diagnosis of COVID-19
3. Patients with mild to moderate COVID-19 infection having either one of the following criteria:PaO2/FiO2:200-300 OR Respiratory rate >= 24/min and SaO2/SpO2 > 90% on room air
4. Subjects willing to give written informed consent
5. Subjects able to take the drug orally and comply with the study protocol
6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry
1. Patients with persistent vomiting
2. Critically ill patients
3.P/F ratio less than 200 (moderate-severe ARDS)
4.Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65)
5.Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections
6.Patients with altered mental state
7.Patients with multiple organ failure requiring ICU monitoring and treatment
8.Patients with respiratory failure and requiring mechanical ventilation
9.Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results.
10.Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
11.Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission
12.Patient who have participated in another investigational study within 3 months prior to enrollment in this study
13.Investigators, study personnel, sponsorâ??s representatives and their first-degree relatives.
14.Pregnant subjects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time (Days) to clinical improvement from study enrollmentTimepoint: Day 0, Day 5 and Day 10
- Secondary Outcome Measures
Name Time Method