A Phase 2 interventional study of Angiotensin 1-7 in COVID-19, sponsored by Rambam Health Care Campus. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Rambam Health Care Campus · Phase 2, Interventional, and Treatment
Phase 2 ,double blind, randomized study of therapy with Angiotensin 1-7 in COVID-19 patients. 120 confirmed SARS-CoV-2 infected patients who exhibit moderate- clinical symptoms including dyspnea, cough and fever, hospitalized in the KETER department in several hospitals in Israel, will be enrolled. 60 patients will receive Ang 1-7 subcutaneously 500 mcg/kg /day. 60 patients will receive placebo : NaCl 0.9% 2 ml -control arm .
Treatment duration: 14 days or until clinical improvement that enables discharge from hospital.
(the shortest time will be the limiting factor in treatment duration). Follow-up-30 days. 14-30 days after discharge from hospital: we will contact the patient via phone to ask questions related to any possible adverse reaction to the drug and general health.
The working hypothesis behind this study is that the deleterious effects of SARS-CoV-2 are largely attributed to the deprivation of the affected target cells from their advantageous ACE-2-Ang 1-7-MasR machinery on one hand, and to the use of ACE2 as a Trojan horse to infect and destroy these cells on the other in a vicious feed-forward cycle.
120 confirmed SARS-CoV-2 infected patients who exhibit moderate- clinical symptoms including dyspnea, cough and fever, hospitalized in the KETER department in several hospitals in Israel, will be enrolled. 60 patients will receive Ang 1-7 subcutaneously 500 mcg/kg /day. 60 patients will receive placebo : NaCl 0.9% 2 ml -control arm .
Treatment duration: 14 days or until clinical improvement that enables discharge from hospital.
All patients will be treated by Dexamethasone and Remdesivir, according to the published guidelines. Moreover, if other promising medications will be approved for COVID-19, the patients will also be treated by these medications. The current trial will not exclude promising COVID-19 treatments.
Each patient will be closely followed up, where routine physical sings, respiratory and hemodynamic parameters will be documented. In addition, the following complications will be monitored: thromboembolic events, myocarditis, impaired liver function and acute kidney injury. Allergic reactions will be treated by corticosteroids, antihistamines and adrenalin if needed. Patients experiencing allergic reactions will be excluded from continuing the trail.
In addition, biochemical (kidney function tests, electrolytes, liver enzymes, albumin, protein, ferritin, troponin- 5 ml) and hematological (CBC-(3 ml), and coagulation tests-(3 ml)) analysis will be performed on the day of enrollment and every 3 days . Other blood tests for immunophenotyping, cytokines, COVID-19 PCR, Angiotensin II (Ang II) levels, Angiotensin 1-7 (Ang 1-7) levels, ACE and ACE-2 will be collected at baseline and at days 6,15,21 and 30 days after enrollment. and every week ( 2 chemistry (10 ml) and 2 CBC tubes (10 ml)).
In addition chest X-ray will be performed at enrollment and at days 6,15,21 and 30 days after enrollment.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Moderate lung disease, defined by the following respiratory variables (meets one of the following criteria): lung infiltrates (evident by chest X-ray) not attributable to other causes plus one of the following:
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Exclusion Criteria:
Ang 1-7 subcutaneously 500 mcg/kg /day
Drug: Angiotensin 1-7
NaCl 0.9% subcutaneously 2.0 cc once a day
Drug: Angiotensin 1-7
Ang 1-7 subcutaneously 500 mcg/kg /day
Need for mechanical ventilation
Patient is intubated
Time frame: Any time from randomization up to 30 days of last study treatment dose
Death
death certificate
Time frame: Any time from randomization up to 30 days of last study treatment dose
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Rambam Health Care Campus