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

NCT ID: NCT06857318

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-01-01

Brief Summary

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.

Conditions

COVID 19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colostrum Treatment Group

Group Type: EXPERIMENTAL

Colostrum Nasal Spray

Intervention Type: BIOLOGICAL

24 hours use of nasal spray of colostrum from MERS-CoV positive camels- 6 doses total

Control

Group Type: PLACEBO_COMPARATOR

Water for injection

Intervention Type: OTHER

24 hours use of a nasal spray of water for injection- 6 doses total

Interventions

Colostrum Nasal Spray

24 hours use of nasal spray of colostrum from MERS-CoV positive camels- 6 doses total

Intervention Type: BIOLOGICAL

Water for injection

24 hours use of a nasal spray of water for injection- 6 doses total

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Hila Elinav

Director of Hadassah AIDS center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadassah Hebrew University

Jerusalem, , Israel

Countries

Israel

Other Identifiers

HMO-238-20

Identifier Type: -

Identifier Source: org_study_id