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

Phase 3

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/08/026957
• Lead Sponsor: Corival Lifesciences Private Limited

Brief Summary

Primary Study Objective: The objective of this studyis to evaluate the efficacy of a combination of the Herbal  and Nutraceutical formulations Immunofreetablets and Regimmune capsules on mild and moderate covid19 patients incomparison with the standard treatment protocol in use in Hospitals.

Design: An open label, multicentre, randomized,comparative, parallel group, controlled study

Setting: The study was done as per ICH GCPguidelines at 4 sites with approval from respective Ethics committees.

Participants: 50 subjects (mean age 43.2 years)received the test product (Immunofree tablets and Reginmune Capsule) and 50subjects (mean age 41.76 years) received Standard of care treatment as control.Intervention: 2 tablets thrice a day at an interval of 4-5 hours for 10 daysand 1 Reginmune capsule twice a day for 10 days

Primary Outcome Measure: The analysis was done onefficacy pathological tests like RT-PCR, Procalcitonin, ESR, C-reactiveprotein, eosinophil, Temperature, SpO2, Respiratory rate & D-dimer alongwith the Clinical and Subject’s Global Assessment of Symptoms. The assessmentswere done on day 0, day 5, and day 10.

Results: 88% of the subjects in Immunofree tablet +Reginmune capsule group were shown to be virologically cured (RT/PCR negative)day 5 and discharged from the hospitals at Day 5 when compared to 72% (RT/PCRNegative) of the subjects in the standard of care group at Day 5. At Day 10 oftreatment all patients were virologically cured in Immunofree tablet +Reginmune capsule when compared to 88% of the patients cured in the Standard ofCare. The global assessment shows quicker symptoms relief in the test groupthan the control group. In most other pathological assessments, the individualarm data for the two arms is significant, but their comparative data issimilar.

In conclusion, the time to 2-point clinicalimprovement as per 7 point ordinal WHO scale was seen in favour in theImmunofree tablet + Reginmune capsule group when compared to the standard ofcare. The results were significant.

The Immunofree tablet + Reginmune capsule treatmentwas very effective in virological results. Immunofree tablet + Reginmunecapsule treatment reduced Covid 19 symptoms when compared to the baseline.

It reduces Inflammatory marker CRP levels whencompared to the baseline and also when compared to the standard of care.

It increases the Immune parameters of Totalleukocyte counts, Platelets, Neutrophils and Lymphocytes when compared toStandard of care.

It improves the Blood oxygen saturation levels.

It improved the chest findings in Chest X-Ray.

All the biochemical tests were normal at baselineand post study.

There were no serious adverse events reported in thestudy.

Overall Immunofree tablet + Reginmune capsule groupwas effective in treating the Covid-19 patients than the standard of care. TheImmunofree tablet + Reginmune capsule group was tolerated very well in Covid-19patients. The overall results in the Intervention are encouraging for Mild toModerate Covid19 cases.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-12
• Study Start: 2020-07-08
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

• Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive).
• 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

• 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 subject’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, sponsor’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 enrollment	Day 0, Day 5 and Day 10

Secondary Outcome Measures

Name	Time	Method
Responders as assessed by the global assessment of symptoms	Day 0 - Day 10
Rate of patients showing improvement of 2 points in 7 category ordinal scale	Day 0, Day 5±1 and Day of discharge i.e Day 10±1
Clinical status as assessed by the 7-point ordinal scale	Day 0, Day 5±1 and Day of discharge i.e Day 10±1
Proportion of participants in each group with normalization of fever	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 24h	Day 0, Day 5±1 and Day of discharge i.e Day 10±1
Time to first negative SARS-CoV-2 PCR in NP swab	Day 0, Day 5±1 and Day of discharge i.e Day 10±1
Duration of oxygen therapy	Day of discharge
Proportion of participants in each group with need for mechanical ventilation	Day of discharge
Duration of hospitalization	Day of discharge
Value of coagulation indicators D-dimer (DD)	Day 0, Day 5±1 and Day of discharge i.e Day 10±1

Trial Locations

Locations (4)

Abhinav multispeciality hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Govt Medical College and Govt General Hospital ( Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Lokmanya Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Parul Institute of Ayurveda and Research Parul University; 🇮🇳 Vadodara, GUJARAT, India

Abhinav multispeciality hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr Sudhirkumar bhatnagar

Principal investigator

9545069465

drabhijitmunshi@gmail.com