Colostrum from MERS-CoV Seropositive Camels for SARS-CoV-2 Infection - a Placebo-controlled Randomized Trial.

Hadassah Medical Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

COVID 19

Treatments

Biological: Colostrum Nasal Spray

Other: Water for injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06857318

HMO-238-20

Details and patient eligibility

About

The study aims to study the efficacy of colostrum from MERS-CoV-positive camels applied as a nasal spray to COVID-19 patients for treatment and prevention of SARS-CoV-2 infection. This study will compare the usage of colostrum to placebo.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age over 18 years.
Laboratory-proven infection with COVID-19 using PCR or another approved kit
Hospitalized / community setting-at low-moderate clinical risk according to the NEWS-2 scale with a score of 0-10.
Onset of symptoms up to 7 days before inclusion
Can sign informed consent
Willingness and ability to participate in research

Exclusion criteria

Pregnant women or lactating
Lack of judgment (psychiatric disorder or dementia)
Immunosuppressed - HIV with CD4 below 500, chemotherapy, steroids - more than 5 mg per day, solid organ transplants, bone marrow transplants, active hematological or oncological malignancies, biological therapy
Neutropenia (less than 2000 neutrophils per cubic meter) or thrombocytopenia (platelet count less than 50000 per cubic meter).
Acute or chronic sinusitis.
Nasal polyps or any pathology in the nasal cavity
Cystic fibrosis
Significant disturbance in liver functions (AST/ALT more than 5 times the ULN)
Significant renal dysfunction (GFR lower than 30 ml per minute)
Known allergy to colostrum or cow's milk
Use of another study drug