An interventional study of Recombinant human angiotensin-converting enzyme 2 (rhACE2) in COVID-19, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Withdrawn at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.
This is a small pilot study investigating whether there is any efficacy signal that warrants a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It is not expected to produce statistically significant results in the major endpoints. The investigators will examine all of the biologic, physiological, and clinical data to determine whether a Phase 2B trial is warranted.
Primary efficacy analysis will be carried only on patients receiving at least 4 doses of active drug. Safety analysis will be carried out on all patients receiving at least one dose of active drug.
It is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to have at least 12 evaluable patients in each group.
Experimental group: 0.4 mg/kg rhACE2 IV BID and standard of care Control group: standard of care
Intervention duration: up to 7 days of therapy
No planned interim analysis.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.
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Laboratory diagnosis:
Fever:
Axillary temperature >37.3℃
Respiratory variables (meets one of the following criteria):
Exclusion Criteria:
0.4 mg/kg IV BID for 7 days (unblinded) + standard of care
Drug: Recombinant human angiotensin-converting enzyme 2 (rhACE2)
Standard of care; no placebo
In this study, the experimental group will receive 0.4 mg/kg rhACE2 IV BID for 7 days.
Time course of body temperature (fever)
Compare the time course of body temperature (fever) between two groups over time.
Time frame: 14 days
Viral load over time
Compare viral load between two groups over time.
Time frame: 14 days
P/F ratio over time
PaO2/FiO2 ratio
Time frame: 14 days
Sequential organ failure assessment score(SOFA score) over time
SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.
Time frame: 14 days
Pulmonary Severity Index (PSI)
Time frame: 14 days
Image examination of chest over time
Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.
Time frame: 14 days
Proportion of subjects who progressed to critical illness or death
Time frame: 14 days
Time from first dose to conversion to normal or mild pneumonia
Time frame: 14 days
T-lymphocyte counts over time
Time frame: 14 days
C-reactive protein levels over time
Time frame: 14 days
Angiotensin II (Ang II) changes over time
Time frame: 14 days
Angiotensin 1-7 (Ang 1-7) changes over time
Time frame: 14 days
Angiotensin 1-5 (Ang 1-5) changes over time
Time frame: 14 days
Renin changes over time
Time frame: 14 days
Aldosterone changes over time
Time frame: 14 days
Angiotensin-converting enzyme (ACE) changes over time
Time frame: 14 days
Angiotensin-converting enzyme 2 (ACE2) changes over time
Time frame: 14 days
Interleukin 6 (IL-6) changes over time
Time frame: 14 days
Interleukin 8 (IL-8) changes over time
Time frame: 14 days
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time
Time frame: 14 days
Plasminogen activator inhibitor type-1 (PAI-1) changes over time
Time frame: 14 days
Von willebrand factor (vWF) changes over time
Time frame: 14 days
Tumor necrosis factor-α (TNF-α) changes over time
Time frame: 14 days
Soluble receptor for advanced glycation end products (sRAGE) changes over time
Time frame: 14 days
Surfactant protein-D (SP-D) changes over time
Time frame: 14 days
Angiopoietin-2 changes over time
Time frame: 14 days
Frequency of adverse events and severe adverse events
Time frame: 14 days
This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University