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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06857318
Enrollment
43
Registered
2025-03-04
Start date
2023-05-01
Completion date
2024-01-01
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19

Keywords

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

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.

Interventions

BIOLOGICALColostrum Nasal Spray

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

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

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Viral Load and Infectivity24 hoursViral load and infectivity will be measured using nasal swabs

Secondary

MeasureTime frameDescription
Undetectable Viral Load and Non-infectious Virus72 hoursViral load and infectious virus will be assessed by nasal swabs

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026