DEFINE - Evaluating therapies for COVID-19

Phase 2

• Conditions: Prevention of lung injury in patients with COVID-19 (SARS-CoV-2 infection); Respiratory; COVID-19 (SARS-CoV-2 infection)

• Registration Number: ISRCTN14212905
• Lead Sponsor: niversity of Edinburgh

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34911721/ (added 17/12/2021) 2022 Preprint results in https://doi.org/10.1101/2021.12.21.21267983 (added 07/11/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35152152/ (added 07/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-22
• Last Update Posted: 21 November 2022
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Main inclusion criteria (all appendices)
1. Provision of informed consent
2. Aged at least 16 years
3. COVID-19 positive test (lateral flow followed by confirmatory PCR or PCR only) result within last 14 days
4. If the patient is of child bearing potential*, or is a male with a female partner with child bearing potential the patient, and their partner(s), agree to use medically-accepted contraception.

(added 22/09/2022) Appendix 3 Specific inclusion criteria:
For this Appendix all above inclusion criteria must be met. In addition, the following criteria must also be met:
1. Patient deemed capacitated to provide informed consent for themselves.
2. Maintaining oxygen saturations of =92% at time of screening and for 24 hours prior to commencement of infusion.
3. If the patient is of child bearing potential, or is a male with a female partner with child bearing potential, the patient, and their partner(s), agree to use a highly effective method of contraception for 4 weeks following the date of the infusion. Methods considered highly effective are those that achieve a failure rate of less than 1% per year when used consistently. This includes:
3.1. Combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation
Oral
Intravaginal
Transdermal
3.2. Progesterone-only hormonal contraception associated with inhibition of ovulation:
Oral
Injectable
Implantable
3.3. Intrauterine device (IUD)
3.4. Intrauterine hormone-releasing system (IUS)
3.5. Bilateral tubal occlusion
3.6. Vasectomised partner
3.7. Sexual abstinence

Exclusion Criteria

1. Current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled cardiac disease (NYHA class IV), uncontrolled renal disease (eGFR < 30 mL/min/1.73 m²), severe liver dysfunction (ALT/AST > 5x ULN) or bone marrow failure (Hb < 8g/dL AND ANC < 0.5 mm³ AND platelet count <50,000 µL)
2. Women who are pregnant or breastfeeding.
3. Participation in another clinical trial of an investigational medicinal product (CTIMP)
4. Known hypersensitivity to the IMP or excipients.
5. Pre-existing or concomittant use of off-label treatments for COVID-19

Study & Design

• Study Type: Interventional
• Study Design: Not specified