Angiotensin 1-7 as a Therapy in the Treatment of COVID-19

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborator: Constant Therapeutics LLC
• Treatments: Angiotensin I (1-7)

Criteria

Inclusion Criteria:

1. Respiratory specimen is positive for SARS-CoV-2 nucleic acid by RT-PCR

2. Fever: Temperature >37.8℃

3. 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:

• Respiratory rate: RR ≥25 breaths/min

• Oxygen saturation ≤94 % at rest on room air

4. HBsAg negative, HCV negative; HIV negative

5. Informed consent

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Exclusion Criteria:

• Age <18 years

• Pregnant or breast-feeding woman or with positive pregnancy test result

• PaO2/FiO2 ≤100 mmHg / mechanical ventilation

• Severe organ failure - not expected to survive for >7 days

• Hemodynamically unstable in the preceding 10 hours (MAP ≤65 mmHg, or SAP <90 mmHg, DAP <60 mmHg, vasoactive agents are required)

• Patient on ECMO

• Patient in other therapeutic clinical trial within 30 days before enrolment

• Chronic immunosuppression: current autoimmune diseases or patients who received immunotherapy within 30 days before enrolment

• Hematologic malignancy (lymphoma, leukemia, multiple myeloma)

• Other patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe congestive heart failure( NYHA class III or IV, EF less than 30%,) liver cirrhosis , chronic kidney disease stave IV, V(e GFR<30 ml/min), chronic obstructive lung disease: GOLD C,D : ≥2 exacerbations or ≥1 that required hospitalization, FEV1<50%, GOLD 3,4)

• Atopic patients suffering from allergies