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Clinical Trials/EUCTR2020-001052-18-DE
EUCTR2020-001052-18-DEActive, not recruitingPhase 1

A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for European Union/United Kingdom Sites - Adaptive COVID-19 Treatment Trial in the EU & UK (ACTT-EU/UK)

Regents of the University of Minnesota0 sites800 target enrollmentStarted: March 27, 2020Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
800
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Admitted to a hospital with synmptoms suggestive of COVID-19 infection
  • •2. Subject (or legally authorised representative) provides informed consent prior to initiation of any study procedures
  • •3. Subject (or legally authorised representative) understands and agrees to comply wiht planned study procedures
  • •4.Male or non-pregnant female adult = 18 years of age at time of enrollment
  • •5. Has laboratory - confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen as documented by either of the following: PCR positive in sample collected < 72 hours prior to randomisation OR PCR positive in sample collected = 72 hours prior to randomisation, documented inabilty to obtain a repeat sample (e.g. due to lack of testing supplies limited testing capacity, results taking > 24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection
  • •6. Illness of any duaration, and at least one of the following:
  • •Radiographic infiltrates by imagin (chest X-ray, CT-scanm etc.) OR SpO2 = 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation
  • •7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not incluidng hormonal contraception from the time of screening through Day 29
  • •8. Agrees to not participate in another clinical trial for treatment of COVID-19 or SARS-CoV-2 thorugh Day 29
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 400
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

  • •1. ALT/AST > 5 times the upper limit of normal
  • •2. Estimated glumerular filtration rate (eGFR) < 30 ml/min (inlcuding patientes receiving hemodialysis or hemofiltration)
  • •3. Pregnancy or breast feeding
  • •4. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours
  • •5. Allergy to any study medication

Investigators

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