Status:
COMPLETED
Effect of a Combination of Treatment of Reginmune Capsule and Immunofree Tablets in the Treatment of Mild to Moderate COVID-19 Patients
Lead Sponsor:
PUNEET MITTAL
Conditions:
Treatment of Covid-19 Virus Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
While novel drug discovery and vaccine studies are time taking process, re-purposing old drugs against the COVID-2019 epidemic can help identify treatments, with known pre-clinical, pharmacokinetic, p...
Detailed Description
The symptoms of COVID-19 are mainly for respiratory disorders and similar to severe acute respiratory symptoms. The common signs of infection observed in COVID-19 patients include respiratory symptoms...
Eligibility Criteria
Inclusion
- Gender: Either male or non-pregnant, non-lactating female aged \> 18-70
- Patients with RT-PCR confirmed diagnosis of COVID-19
- Patients with mild to moderate COVID-19 infection having either one of the following criteria: oPaO2/FiO2:200-300 OR Respiratory rate ? 24/min and SaO2/SpO2 \> 90% on room air
- Subjects willing to give written informed consent
- Subjects able to take the drug orally and comply with the study protocol
- Women of child bearing potential must have a negative urine pregnancy test prior to study entry
Exclusion
- Patients with persistent vomiting
- Critically ill patients
- P/F ratio less than 200 (moderate-severe ARDS)
- Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65)
- Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections
- Patients with altered mental state
- Patients with multiple organ failure requiring ICU monitoring and treatment
- Patients with respiratory failure and requiring mechanical ventilation
- 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 subject's participation in the study or interferes with the interpretation of the study results.
- Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
- Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission
- Patient who have participated in another investigational study within 3 months prior to enrollment in this study
- Investigators, study personnel, sponsor's representatives and their first-degree relatives.
- Pregnant subjects
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04494204
Start Date
August 7 2020
End Date
December 20 2020
Last Update
December 22 2020
Active Locations (3)
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1
Govt Medical College and Govt General Hospital (Old RIMSGGH)
Srikakulam, Andhra Pradesh, India, 532001
2
Parul Institute of Ayurveda and Research Parul University
Vadodara, Gujarat, India, 391760
3
Lokmanya Hospital
Pune, Maharashtra, India, 411033