A multiple dosing study to demonstrate the safety, tolerability, pharmacokinetics and efficacy potential of intravenously administered ANXV (a recombinant human Annexin A5) in patients with confirmed moderate to severe COVID-19; The CO-ANNEXIN Study.

Phase 2

• Conditions: COVID-19 pneumonia; SARS-COV-2 infection; 10047438; 10003816; 10037454

• Registration Number: NL-OMON51226
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

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)
6. Mentally Competent

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified