A trial of sodium-copper-chlorophyllin given along with treatment of physicianâ??s choice versus treatment of physicianâ??s choice in asymptomatic or mildly symptomatic patients with Covid-19
- Conditions
- Health Condition 1: J00-J06- Acute upper respiratory infectionsHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/02/030986
- Lead Sponsor
- IDRS Labs Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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:
1. Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen.
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.
3. Have absolute lymphocyte count (ALC) less than 1000 cells/mm3, at the time of screening.
4. Have an oxygen saturation of >94% while breathing ambient air.
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.
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:
1. Have pneumonia confirmed by chest imaging.
2. Patients receiving mechanical ventilation or ECMO or who have multiorgan failure.
3. Pregnant or lactating females.
4. Therapy with an investigational agent within the past 30 days from screening.
5. Treatment with any drug having anti-SARS-CoV-2 activity prior to screening including hydroxychloroquine and other antiviral agents.
6. Any other conditions, including moderate to severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of patients who either continue to be COVID positive by RT-PCR at Day 5. <br/ ><br>OR <br/ ><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/ ><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
- Secondary Outcome Measures
Name Time Method 1. Proportion of patients with lymphocyte recovery (ALC more than or equal to 1000/mm3) at Day 5. <br/ ><br>2. All-cause mortality at 28 days after randomization (28-day mortality) in test arm as compared to control arm. <br/ ><br>3. Biomarker response (Cytokines, chemokines, CRP and D-dimer) at Screening, Day 5 and Day 10 in test arm as compared to control arm <br/ ><br>4. Incidence of adverse events and treatment emergent adverse events in each arm during the study.Timepoint: Blood samples will be collected prior to starting study treatment, Day 5 (12 ± 2 hours after morning dose) and Day 10/11 (12 ± 2 hours after morning dose).