COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51800

Dr Ravi Alamchandani

Ravi.A1950@veedacr.com

2021-02-04

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Male and non-pregnant female patients more than or equal to 18 years of age will be eligible if they meet all of the following criteria: <br/ >1. Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen. <br/ >2. Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion. <br/ >3. Have absolute lymphocyte count (ALC) less than 1000 cells/mm3, at the time of screening. <br/ >4. Have an oxygen saturation of >94% while breathing ambient air. <br/ >5. Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion. <br/ >6. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.

Patients will not be eligible for this study if any of the following in present at the time of study inclusion: <br/ >1. Have pneumonia confirmed by chest imaging. <br/ >2. Patients receiving mechanical ventilation or ECMO or who have multiorgan failure. <br/ >3. Pregnant or lactating females. <br/ >4. Therapy with an investigational agent within the past 30 days from screening. <br/ >5. Treatment with any drug having anti-SARS-CoV-2 activity prior to screening including hydroxychloroquine and other antiviral agents. <br/ >6. Any other conditions, including moderate to severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study. <br/ >

2

IDRS Labs Private Limited

18

99

India

Mild disease at enrollment

1: Mild disease at enrollment

60

1. Proportion of patients who either continue to be COVID positive by RT-PCR at Day 5. <br/ >OR <br/ >2. Suffer clinical deterioration by Day 10 from the date of randomization (excluding the date of randomization) in test arm as compared to control arm. <br/ >Timepoint: RT-PCR will be performed on day 5 after the 5th dose and the RT-PCR negative patients will be discharged on Day 6

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

Phase 2

[{"arm_notes": "", "treatment_id": 278, "treatment_name": "Chlorophyllin", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]