The CO-ANNEXIN study; assessing the efficacy and safety of ANXV (recombinant Annexin A5) in moderate tosevere COVID-19.

Phase 1

• Conditions: moderate to severe COVID-19 pneumonia; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-002200-12-NL
• Lead Sponsor: MUMC AZm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-17
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Patients must be at least 18 years of age or older, with clinically evident or otherwise confirmed moderate to severe COVID-19
pneumonia, with PCR-confirmed presence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
They have to be in need for oxygen supply, via high flow nasal oxygen (optiflow).
Inclusion criteria
1. Patients hospitalized for laboratory documented SARS-CoV2 infection (qRT-PCR).
2. Males between 18 and 75 years or Females of non-reproductive age or capacity, i.e post-menopausal or sterile, and between 18
and 75 years.
3. Signed informed consent by patient
4. Hospitalized with a resting oxygen saturation on room air of <92 %, AND receiving high flow nasal oxygen.
5. Elevated LDH (>350U/L, n=97-247 U/l)
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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject requiring mechanical ventilation/ extracorporeal membrane oxygenation and in-tubated for mechanical ventilation.
2. Severe COPD, defined by continuous use of long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months in the
home situation.
3. Subject with severe renal impairment (eGFR < 30 ml/min)
4. Subjects on chronic dialysis.
5. Subject with an active malignancy within the last three months, and/or a risk of mortality >50% within 6 months.
6. Bleeding Risk:
a. Clinical: Active bleeding; head trauma, intracranial surgery or stroke within 3 months; history of intracerebral arteriovenous
malformation, cerebral aneurysm or mass lesions of the central nervous system; cerebral haemorrhage; history of a bleeding
diatheses; gastrointestinal bleeding within 6 weeks; presence of an epidural or spinal catheter; contraindication for IV therapeutic
UFH.
b. Laboratory: Platelet count <50 x109/L, INR >3.0 or baseline aPTT =45 seconds prior to enrolment.
7. Use of any of the following treatments: UFH to treat a thrombotic event within 12 hours before enrolment; thrombolytic therapy
within 3 previous days;
8. Confirmed antiphospholipid syndrome, systemic lupus erythematosus and other auto-immune diseases (at discretion of PI)
9. Confirmed thalassemias (e.g sickle cell disease)
10. Cardiopulmonary resuscitation in previous 7 days.
11. Liver failure defined as Child-Pugh Score Class C.
12. Abnormal liver function (AST >5xULN, ALT >5xULN)
13. Life expectancy of <24 hours
14. Treating physician refusal.
15. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol.
16. Participation in any other investigational drug study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified