Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Multi-center multinational-controlled study in Israel, Brazil, Spain, and South-Africa.

240 adult patients who suffer from moderate COVID-19 infection. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.

After Screening visit, the study drug will be administrated twice a day morning and evening (every 12 hours) during (day 1 and day 2) The patients will be randomized in 1:1:1 ratio to study drug (CimetrA) in two dosages in addition to Standard of Care - Arm 1, 2 or (Placebo) in addition to Standard of Care- Arm 3.

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

Details

• Lead Sponsor: MGC Pharmaceuticals d.o.o
• Treatments: Fibrin fragment D

Criteria

Inclusion Criteria:

1. Confirmed by PCR test SARS-CoV-2 infection (according to nationally authorized laboratory criteria)

2. Hospitalized patient with COVID-19 of moderate stable or worsening severity not requiring ICU admission (defined by NIH criteria - fever, cough, dyspnea, fast breathing, but no signs of severe pneumonia, including SpO2 ≥ 94% on room air).

3. Age: 18 years old and above.

4. Subjects must be hospitalized

5. Ability to receive treatment by spray into the oral cavity

Exclusion Criteria:

1. Tube feeding or parenteral nutrition.

2. Patients with scores 5 or above per the Ordinal Scale for Clinical Improvement published by the WHO. (i.e., who need oxygen supply beyond use of nozzles or simple mask)

3. Need for admission to ICU during the present hospitalization at any time prior to completion of the recruitment to the study.

4. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.