Phase 2
Completed N=181
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Source: ClinicalTrials.gov NCT04335136 ↗Enrolled (actual)
181
Serious AEs
12.4%
Results posted
Aug 2021
Primary outcomePrimary: All Cause-death or Invasive Mechanical Ventilation — 9; 12 Participants — p=0.5207
Summary
Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with COVID-19 to block viral entry and decrease viral replication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Cause-death or Invasive Mechanical Ventilation |
9; 12 | 0.5207 |
| SECONDARY Lactate Dehydrogenase (LDH) Level |
5.82; 5.80 | — |
| SECONDARY Mortality |
9; 7 | — |
| SECONDARY Ventilator-free Days (VFD) |
17.2; 16.7; 17.4; 16.7; 18.9; 17.9 | — |
| SECONDARY Time to Death |
NA; NA | — |
| SECONDARY Number of Responders, Defined as ≥2 Improvement in World Health Organization (WHO)'s 11-Point Score System at Days 7, 10, 14 and 28 |
2; 0; 17; 13; 38; 32 | — |
| SECONDARY Time to Hospital Discharge |
14; 14 | — |
| SECONDARY Viral Ribonucleic Acid (RNA). |
27996; 3900; 20931; 13681; 9825; 11912 | — |
| SECONDARY Time to a 2-point Decrease in WHO's 11-Point Score System |
27; 27 | — |
| SECONDARY Number of Patients With Any Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge |
7; 7; 86; 88 | — |
| SECONDARY Time to First Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge |
NA; NA | — |
| SECONDARY PaO2/FiO2 Value |
223.07; 185.14; 218.74; 192.21; 290.00; 186.62 | — |
| SECONDARY Modified Sequential Organ Failure Assessment Score (mSOFA Score, Total Score) |
2.6; 2.2; 1.8; 1.6; 1.0; 1.0 | — |
| SECONDARY Lymphocyte Count |
1.13; 1.06; 1.25; 1.16; 1.45; 1.62 | — |
| SECONDARY C-reactive Protein Levels |
56.0; 62.8; 36.1; 43.7; 21.7; 26.1 | — |
| SECONDARY D-Dimer |
1341; 1187; 1109; 881; 1208; 1139 | — |
| SECONDARY Log-transformed Levels of LDH |
5.91; 5.87; 5.86; 5.88; 5.77; 5.75 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized male or female
- Diagnosed to be COVID-19 POSITIV
- Signed Inform Consent Form
Exclusion Criteria
- Any patient whose clinical condition is deteriorating rapidly
- Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
- Pregnant females as determined by positive serum or urine hCG test prior to dosing
- Lung transplantation
- Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis or peritoneal dialysis
- There are other uncontrolled co-morbidities that increase the risks associated with the study drug administration, that are assessed by the medical expert team as unsuitable
- Patient in clinical trials for COVID-19 within 30 days before ICF
- Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)
Data sourced from ClinicalTrials.gov (NCT04335136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.