Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: 1. Immunofree 500 mg tablets
2. Reginmune 750 mg capsule: 2 tablets Immunofree 500 mg tablets thrice a day for 10 days and 1 capsule Reginmune 750 mg twice a day for 10 days
Control Int
Sponsors
Corival Lifesciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (Days) to clinical improvement from study enrollmentTimepoint: Day 0, Day 5 and Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical status as assessed by the 7-point ordinal scaleTimepoint: Day 0, Day 5±1 and Day of discharge i.e Day 10±1;Duration of hospitalizationTimepoint: Day of discharge;Duration of oxygen therapyTimepoint: Day of discharge;Proportion of participants in each group with need for mechanical ventilationTimepoint: Day of discharge;Proportion of participants in each group with normalization of feverTimepoint: Day 0, Day 5±1 and Day of discharge i.e Day 10±1;Proportion of participants in each group with oxygen saturation more than 94% on room air for more than 24hTimepoint: Day 0, Day 5±1 and Day of discharge i.e Day 10±1;Rate of patients showing improvement of 2 points in 7 category ordinal scaleTimepoint: Day 0, Day 5±1 and Day of discharge i.e Day 10±1;Responders as assessed by the global assessment of symptomsTimepoint: Day 0 - Day 10;Time to first negative SARS-CoV-2 PCR in NP swabTimepoint: Day 0, Day 5±1 and Day of discharge i.e Day 10±1;Value of coagulation indicators D-dimer (DD)Timepoint: Day 0, Day 5±1 and Day of discharge i.e Day 10±1 | — |
Countries
India
Contacts
Public ContactPuneet Mittal
Mittal Global Clinical Trial Services
Outcome results
None listed