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Completed

NCT Number: NCT06857318

Colostrum From MERS-CoV Seropositive Camels for SARS-CoV-2 Infection - 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.

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Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hadassah Hebrew University

Jerusalem, 91120, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colostrum Nasal Spray

Biological

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

Water for injection

Other

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

Primary outcomes

  1. Viral Load and Infectivity

    Time frame: 24 hours

    Viral load and infectivity will be measured using nasal swabs

Secondary outcomes

  1. Undetectable Viral Load and Non-infectious Virus

    Time frame: 72 hours

    Viral load and infectious virus will be assessed by nasal swabs

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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