COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48880

Dr R Senthilkumar

mail@medinippon.jp

2020-12-28

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Adult subjects between 18 and 65 years (both ages and sexes inclusive) who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government. <br/ >2. Subjects with co-morbidities can be included. To be analysed as cohort. <br/ >3. Subjects who are found to be Covid19 positive requiring hospitalization. (symptomatic or asymptomatic) <br/ >4. Subject and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period. <br/ >5. Subjects who are willing not to participate in any other clinical trial during participation in the current trial. <br/ >

1. Subjects who have previously been infected with SARS-CoV2 (symptomatic or asymptomatic) and recovered. <br/ >2. Subjects who are known to be HIV, HBV, HCV positive. <br/ >3. Subjects who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study. <br/ >4. Subjects with complete cancer remission less than 3 years prior to the date of screening. <br/ >5. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation. <br/ >6. Subjects who are on anti-depressants, anti-psychotics. <br/ >7. Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases, except those that are considered etiology of said indication. <br/ >8. Females who are pregnant or nursing or planning to become pregnant during the study period. <br/ >

2

Medi Nippon Health Care Private Limited

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

48

1. Covid19 Clinical Symptoms: Time taken for improvement; complete recovery; recurrence in typical symptoms not limited to pyrexia; respiratory distress; cephalgia; malaise from baseline. <br/ >2. RT PCR: Time taken for negative RT PCR Result from baseline. <br/ >3. RT PCR : Reduction of titer/severity level from baseline.Timepoint: Covid19 Clinical Symptoms: Day 1; Day 15; Day 30 <br/ >RT PCR: Day 1; Day 15; Day 30

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 1955, "treatment_name": "Nichi glucan", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]