A clinical study to understand the effect of Inosine Pranobex in Covid-19 patients when used along with the standard of Care in Covid patients.

Phase 2

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/08/027162

Lead Sponsor: Themis Medicare

Brief Summary: This is an open-label, prospective, comparative, multicentre proof of concept study. This multicentre study is to assess the effect of Tab. Inosine Pranobex as an add-on therapy to the standard of care for of patients in patients with confirmed acute COVID-19infection achieving clinical response, when compared to patients only on standard of care.

Patients suggestive of RT-PCR [nasopharyngeal (preferred) and oropharyngeal swab positive] acute COVID-19 infection will be enrolled into this study with a score between 3 to 5 on the Modified Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1). Both inpatient and outpatients will be enrolled into this study. The Modified WHO Ordinal Scale for Clinical Improvement, physical and systemic examination will be performed on a daily basis for inpatients and at the scheduled protocol visits for outpatients.

The enrolled patients will receive Tab. Inosine Pranobex treatment for a period of 14 days. Patients will be assessed on day 7 (Â±1 day) and day 14 (Â±1 day). A follow-up safety assessment will be done on day 21 (Â±1 day).

Croissance Clinical Research is providing the Data management Support to the clinical study.

**Summary of Results**

**Primary Endpoint****:**

Clinical Response (CR) at Day 14 was observed in 90% patients in IAD+CSC treatment arm vs. 85.37% patients in CSC treatment arm in the ITT population. The difference between the two treatments arms was not statistically significant (p-value: 0.526).

**Secondary Endpoints:**

CR at Day 7 and Day 21 in the IAD+CSC treatment arm and the CSC treatment arm was 57.50% vs. 43.90% (p-value: 0.221) and 90.00% vs. 87.80% (p-value: 0.753). The cumulative number of patients who achieved CR at day 10 in the IAD+CSC treatment group was 83% as compared 61% in CSC group (61%).

Clinical Cure (CC) at Day 7, 14 and 21 in IAD+CSC treatment arm vs. CSC treatment arm in the ITT population was 57.50% vs. 43.90% (p-value: 0.221), 90.00% vs. 85.37% (p-value: 0.526) and 90.00% vs. 87.80% (p-value: 0.753), respectively. The cumulative number of patients who achieved CC at day 10 was 63% in the IAD+CSC group, as compared to 54% the CSC group.

Virological Cure at Day 7, 14 and 21 in IAD+CSC treatment arm vs. CSC treatment arm in the ITT population was 37.50% vs. 34.15% (p-value: 0.753), 75.00% vs. 73.17% (p-value: 0.851) and 82.50% vs. 80.49% (p-value: 0.816), respectively.

For the remaining secondary endpoints, there was no statistically significant difference between the two treatment groups for the ITT population.

Sub-group analysis of patients showed that Inosine Pranobex, when added to standard of care containing Azithromycin and Hydroxychloroquine with or without Ivermectin, produced significantly higher clinical response (CR) at Day-14 than only standard of care (100.00% vs 69.23%; p=0.03).

Overall, there was a trend of (numerically) higher CR, CC and VC on at Day 7, 14 and 21 in the IAD+CSC group compared to the CSC group; however, statistical significance could not be reached. This may be because of small sample size of the study variability in the current standard of care (CSC) among the different sites.

There was no SAE and the drug was well tolerated.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Written signed and dated informed consent (patient or LAR).
2.Either gender, in the age group between 18 to 65 years 3.Patients of laboratory confirmed COVID-19 [nasopharyngeal (preferred) or oropharyngeal swab RT-PCR positive] presenting with WHO listed symptoms of COVID-19 c/o fever, headache, myalgia, cough, throat pain or shortness of breath 4.A score of between 3 to 5 on the WHO Modified Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1) 5.SpO2 â‰¥90% for adults and respiratory rate â‰¤ 30/minute 6.Patients who provide a agree to abide by the study requirements.

Exclusion Criteria

1.Known hypersensitivity to any of the ingredients of the study drug 2.Pregnant and lactating women 3.Children <18 yrs.
of age; elderly >65 years 4.SpO2 <90% for adults and respiratory rate >30/minute 5.History of gout or hyperuricemia (serum uric acid level >6mg/dl), urolithiasis, nephrolithiasis or any degree of renal dysfunction 6.Patients with history of diagnosed primary congenital immunodeficiency, or acquired immunodeficiency like HIV, OR any Genetic or developmental anomaly like Cerebral Palsy, coeliac disease, lactose intolerant, cancer in nor remission stage.
7.Patient who are undergoing treatment with xanthine oxidase inhibitors, uricosuric agents, diuretics, immunosuppressive agents or zidovudine.
8.Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
9.Patients simultaneously participating in another clinical study.
10.Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study 11.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified WHO ordinal scale for clinical improvement between two groups at day 14	at Day 14

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified ordinal scale for clinical improvement for two groups at Day 7 and Day 21	Day 7 and Day 21
Percentage of patients with Grade 1 on WHO modified ordinal scale confirmed (negative swab status) at Day 7, Day 14 and Day 21 for two treatment arms	Day 7, 14 and 21
Percentage of patients with Grade 2 on WHO modified ordinal scale at Day 7, Day 14 and Day 21 for two treatment arms	Day 7, 14 and 21
Time to two-point improvement or becoming asymptomatic (Grade 2 or less) on the modified WHO ordinal scale for patients in the two treatment arms	NIL
Time to resolution of all clinical symptoms of COVID-19 viral infection (Grade 2 on WHO modified ordinal scale) for two treatment arms	NIL
Time to RT-PCR swab negative COVID-19 viral infection (Grade 1 on WHO modified ordinal scale) for two treatment arms	NIL
Mortality rate at Day 21	Day 21
Severity of Dyspnea at Day 7, Day 14 and Day 21	Day 7, 14 and 21
Time to discharge from hospital/duration of hospitalization for inpatients for two groups	NIL
Rate of patients requiring oxygen/ventilation, and/or duration of oxygen use/duration of requiring ventilation for two groups at Day 7 and Day 14	Day 7 and 14
Change in blood levels of NK cell, IL-6 and IL-10 between both treatment groups at Day 7, Day 14 and Day 21 visit.	Day 7, 14 and 21

Trial Locations

Locations (6): All India Institute of Medical Science
🇮🇳
Raipur, CHHATTISGARH, India
Bangalore Medical College and Research Institute
🇮🇳
Bangalore, KARNATAKA, India
District Hospital, Chikalthana
🇮🇳
Aurangabad, MAHARASHTRA, India
Heritage Institute of Medical Sciences
🇮🇳
Varanasi, UTTAR PRADESH, India
Rajendra Institutes of Medical Science
🇮🇳
Ranchi, JHARKHAND, India
Vijay Vallabh Hospital and Medical Research Centre
🇮🇳
(Suburban), MAHARASHTRA, India
All India Institute of Medical Science
🇮🇳Raipur, CHHATTISGARH, India
Dr Ranganath T Ganga
Principal investigator
8004220308
ranganathtg@gmail.com