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

February 27, 2025 updated by: Hila Elinav, Hadassah Medical Organization

Colostrum from MERS-CoV Seropositive Camels for SARS-CoV-2 Infection - from Lab to Human- a Placebo Controlled Randomized Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Hebrew University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Other: Water for injection
24 hours use of a nasal spray of water for injection- 6 doses total
Experimental: Colostrum Treatment Group
Biological: Colostrum Nasal Spray
24 hours use of nasal spray of colostrum from MERS-CoV positive camels- 6 doses total

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral Load and Infectivity
Time Frame: 24 hours
Viral load and infectivity will be measured using nasal swabs
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undetectable Viral Load and Non-infectious Virus
Time Frame: 72 hours
Viral load and infectious virus will be assessed by nasal swabs
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMO-238-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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