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Clinical Trials/CTRI/2022/01/039274
CTRI/2022/01/039274
Other
Phase 2

A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study in Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

Medregen LLC0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Medregen LLC
Status
Other
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1 Subject voluntarily agrees to participate in this study and is able to provide written informed consent or has a legal representative who can provide informed consent or is enrolled under International Conference on Harmonization (ICH) E6 (R2\) 4\.8\.15 emergency use provisions as deemed necessary by the investigator (where permitted according to local law and approved nationally and by the relevant IRB) prior to performing any of the Screening Visit procedures.
  • •2 Males and females over 18 years of age, inclusive, at the time of signing the ICF.
  • •3 Hospitalized, with COVID\-19 symptoms of respiratory illness caused by SARS\-CoV\-2
  • •infection (defined as Scale 5 â?? 7 on the WHO 8\-point ordinal scale for clinical improvement.
  • •4 Laboratory confirmation SARS\-CoV\-2 by real time polymerase chain reaction in the respiratory tract (NP swab, oropharyngeal swab, tracheal aspirate, BAL) lesser or equal to 14 days prior to randomization.
  • •5 Radiologic findings compatible with diagnosis of SARS\-CoV\-2 pulmonary infection
  • •6 Women of childbearing potential must be willing and able to use at least one highly effective contraceptive method for a period from the screening visit until the end of study visit. In the context of this study, an effective method is defined as those which result in low failure rate
  • •(i.e. less than 1 percent per year) when used consistently and correctly such as:
  • •\-Combined (estrogen and progestogen containing) hormonal contraception combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, or transdermal)
  • •\-Progestogen only hormonal contraception associated with inhibition of Ovulation (oral, injectable, implantable)

Exclusion Criteria

  • •1 Participation in any other clinical trial of an experimental treatment for COVID\-19 (remdesivir
  • •use is permitted).
  • •2 Significant pre existing organ dysfunction prior to randomization
  • •\-Lung: Receiving supplemental home oxygen therapy at baseline for pre\-existing medical condition (other than COVID\-19\), as documented in medical record.
  • •\-Heart: Pre\-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record. clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \>180 mm Hg and diastolic blood pressure \>110 mm Hg.
  • •\-Renal: End\-stage renal disease requiring renal replacement therapy or eGFR \<30 mL/min
  • •\-Liver: Severe chronic liver disease defined as Child Pugh Class C
  • •\-Hematologic: Baseline platelet count \<50,000/mm3
  • •3 Concurrent treatment or prior use of drugs with actual or possible direct acting immunomodulatory activity against ARDS in COVID\-19 is prohibited including JAK1/JAK2 inhibitor ruxolitinib, baricitinib and tofacitinib. However, IL\-6 inhibitors such as tocilizumab, sarilumab are allowed if given \>72 hours prior to first study dose. Corticosteroids are permitted throughout the study.
  • •4 History of splenectomy or splenomegaly (spleen weighing \>750 g)

Outcomes

Primary Outcomes

Not specified

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