COVID 19Phase 1/2NCT06857318
Colostrum From MERS-CoV Seropositive Camels for SARS-CoV-2 Infection - a Placebo-controlled Randomized Trial.
A Phase 1/2 study testing Colostrum Nasal Spray and Water for injection in people with COVID 19, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19
- What is being tested?
- Colostrum Nasal Spray and Water for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2023to 1 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID 19
- Being tested
- Colostrum Nasal Spray, Water for injection
- Keywords
- infectivity, viral load, MERS-Cov, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colostrum Nasal SprayBiological
24 hours use of nasal spray of colostrum from MERS-CoV positive camels- 6 doses total
Water for injectionOther
24 hours use of a nasal spray of water for injection- 6 doses total
| Study group | Role | What they receive |
|---|---|---|
| Colostrum Treatment Group | Experimental | Not described Receives: Biological: Colostrum Nasal Spray |
| Control | Placebo comparator | Not described Receives: Other: Water for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load and Infectivity
Viral load and infectivity will be measured using nasal swabs
Measured: 24 hours
Secondary outcomes (1)
Undetectable Viral Load and Non-infectious Virus
Viral load and infectious virus will be assessed by nasal swabs
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 May 2023
- Primary completion31 Aug 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hila Elinav, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857318
- Sponsor's protocol ID
- HMO-238-20
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colostrum From MERS-CoV Seropositive Camels for SARS-CoV-2 Infection - From Lab to Human- a Placebo Controlled Randomized Trial.
- ClinicalTrials.gov ID
- NCT06857318
- Acronym / sponsor ID
- HMO-238-20
- Conditions
- COVID 19
- Keywords
- infectivity, viral load, MERS-Cov, SARS-CoV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colostrum Treatment Group | Experimental | Biological: Colostrum Nasal Spray |
| Control | Placebo comparator | Other: Water for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colostrum Nasal Spray24 hours use of nasal spray of colostrum from MERS-CoV positive camels- 6 doses total | Biological | Colostrum Treatment Group |
| Water for injection24 hours use of a nasal spray of water for injection- 6 doses total | Other | Control |
Primary outcome
Viral Load and Infectivity
Time frame: 24 hours
Viral load and infectivity will be measured using nasal swabs
1 secondary outcome
Undetectable Viral Load and Non-infectious Virus
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Colostrum Nasal Spray and Water for injection in people with COVID 19, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Load and Infectivity (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.