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

NCT06857318 | Completed Phase 1

• 1 other identifier: HMO-238-20
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

infectivity; viral load; MERS-Cov; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Viral Load and Infectivity

  Viral load and infectivity will be measured using nasal swabs

  24 hours

Secondary Outcomes (1)

• Undetectable Viral Load and Non-infectious Virus

  72 hours

Study Arms (2)

Colostrum Treatment Group

EXPERIMENTAL

Biological: Colostrum Nasal Spray

Control

PLACEBO COMPARATOR

Other: Water for injection

Interventions

Colostrum Nasal Spray BIOLOGICAL

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

Colostrum Treatment Group

Water for injection OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Can sign informed consent
• Willingness and ability to participate in research

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

COVID-19

Interventions

Water; Injections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hadassah AIDS center

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: May 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: January 1, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

IL (1)