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Clinical Trials/CTRI/2021/02/030986
CTRI/2021/02/030986
Recruiting
Phase 2

A phase-II, multi-centre, randomized, open label, two arm, controlled 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 SARS-CoV-2 Infection (Covid-19).

IDRS Labs Private Limited0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: J00-J06- Acute upper respiratory infectionsHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: J00-J06- Acute upper respiratory infectionsHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Sponsor
IDRS Labs Private Limited
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
IDRS Labs Private Limited

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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