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

Phase 1

Completed

• Conditions: COVID 19
• Interventions: Biological: Colostrum Nasal Spray; Other: Water for injection

• Registration Number: NCT06857318
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2023-08-31
• Study Completion: 2024-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colostrum Treatment Group	Colostrum Nasal Spray	-
Control	Water for injection	-

Primary Outcome Measures

Name	Time	Method
Viral Load and Infectivity	24 hours	Viral load and infectivity will be measured using nasal swabs

Secondary Outcome Measures

Name	Time	Method
Undetectable Viral Load and Non-infectious Virus	72 hours	Viral load and infectious virus will be assessed by nasal swabs

Trial Locations

Locations (1)

Hadassah Hebrew University; 🇮🇱 Jerusalem, Israel