SARS-CoV InfectionPhase 2/3NCT04684550
Use of Hypochlorous Acid as Prophylaxis in Health Personnel at High Risk of Infection by SARS-CoV 2 (COVID19)
A Phase 2/3 study testing Stabilized hypochlorous acid in people with SARS-CoV Infection and Covid19, run by Hospital Universitario San Ignacio.
Trial summary
The pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Covid19, Infection Viral
- What is being tested?
- Stabilized hypochlorous acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2021to 15 Aug 2021
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Specialist physicians, resident physicians, medical students, and nursing personnel who work at the San Ignacio University Hospital.
- Subjects of any sex over 18 years of age who work as health care personnel, in care services that care for patients with a suspected or confirmed diagnosis of COVID-19 and who are active during the study recruitment.
- That they have not presented general symptoms such as malaise, fever, cough, dyspnea or muscle pain during the last 7 days.
- Subjects negative to the antigen test for COVID-19.
Who cannot join
- Subjects considered as a resolved case of COVID-19 infection, according to guidelines from the Colombian National Institute of Health.
- Health personnel with social distancing due to close contact without personal protective equipment with patients confirmed to be infected or taking any medication as a possible prophylaxis for COVID-19 (example: chloroquine, hydroxychloroquine, azithromycin)
- Health workers who have permits or temporary withdrawal from their hospital work for more than one week during the month of the study.
- Some type of allergy to chlorinated agents or hypersensitivity to HClO
- Known diagnosis of upper airway respiratory disease where COVID-19 such as the common cold, sinusitis, pharyngitis, laryngotracheitis and epiglottitis or lower such as bronchiolitis, pneumonia, and mixed conditions have been ruled out.
- Previous COVID19 infection determined by positive PCR or positive serum antibody titers.
- Any condition that in the principal investigator's discretion renders the subject ineligible to participate in the study.
About this study
Official title: Randomized Controlled Clinical Study (RCT) Phase 3 of the Safety and Efficacy of Hypochlorous Acid in the Prophylaxis of Healthcare Personnel at High Risk of Infection by SARS-CoV2 (COVID19) Versus Placebo
The pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. This requires a coordinated, effective and immediate action on the part of governments, companies, academic entities and even at the individual level.
In the search for new therapeutic and prevention alternatives, the application of hypochlorous acid (HClO) to the nasal mucosa is proposed, a broad-spectrum and fast-acting antimicrobial solution, whose safety has been proven in preclinical trials. The efficacy of HClO has been tested against enveloped and non-enveloped viruses, reducing virus particles without affecting human cells. This solution could contribute to reducing the viral load and the risk of contamination of patients and professionals. This could have an impact on controlling the COVID-19 pandemic.
Read the detailed description
Hypochlorous acid (HClO) is a powerful antimicrobial and antiviral used for the control of various infections, repair and washing of surgical wounds, as well as for disinfection of surfaces. In vivo, it is synthesized by the cells of the immune system for the control of pathogens during phagocytosis and has been synthesized and stabilized for use in different entities.
The therapeutic uses of HClO began in the First World War with the studies of Alexis Carrel and Henry Dakin who obtained a buffered sodium hypochlorite solution (Dakin's solution) which generated ideal concentrations of HClO, using it successfully in washing and treatment of wounds without presenting any damage or undesired effect on the patient's tissues. In 1993, the HClO molecule was stabilized, popularizing its use for the control of predominantly skin infections, treatment of chronic ulcers, closure and cleaning of wounds, management of burned patients, and disinfection of surfaces.
Biologically, it is part of the reactive oxygen species (ROS) synthesized by cells of the immune system (Neutrophils and Macrophages) during an immunological process known as "respiratory burst", during phagocytosis of antigens in reaction with the enzyme myeloperoxidase (MPO), hydrogen peroxide (H2O2) and a chlorine ion. Safety profiles in in vivo models have driven our initiative to use Stabilized Hypochlorous Acid (S-HClO), as an early therapeutic option in patients with SARS-Cov-2 infection or in close contact with COVID-193 positive patients.
Calderon et al and carried out the evaluation of the antimicrobial effect of HClO on potentially pathogenic microorganisms of the oral cavity. The study reports that hypochlorous acid achieved bacterial inhibition of 99.9% at a concentration of 0.05% and a pH of 5.2 per minute of action for different types of bacteria and for infectious microorganisms. Virological tests have also been performed on feline calcivirus (Ebola-like virus), rotavirus, AH1N1, adenovirus and SARS, found to be highly effective after 1 minute of application.
In the face of the COVID-19 pandemic, effective and early treatments are being sought to help prevent the dissipation of the virus (disinfection of surfaces), to neutralize the virus at an early stage when it is lodged in the upper respiratory tract and nose, since this is the Probable route of infection of the ethmoid lamina and later causing viral encephalopathy and treatment of patients with bronchial infection by this virus, decreasing the viral load and causing destruction of the virus. There are reports of the use of HClO in the nasal mucosa in studies in humans, reporting safety and effectiveness, both in adults and in children, which leads us to propose the application of said nasal spray solution, as a prophylaxis in health personnel with a high risk of infection by SARS-CoV-2.
A RCT with the use S-HClO as a prevention treatment for the infection by SARS-CoV-2 in health professionals is proposed.
- Conditions
- SARS-CoV Infection, Covid19, Infection Viral
- Being tested
- Stabilized hypochlorous acid, Placebo
- Keywords
- SARS-CoV Infection, Stabilized hypochlorous acid (S-HClO), Prophylaxis, Health Professionals
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilized hypochlorous acidDrug
Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).
PlaceboDrug
Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Health personnel who work in places of greater risk (hospitals and primary level consultation) with conventional protection elements added to the application of 2 nasal puff every 8 hours of a nasal spray containing 0.9% SSN (placebo) and gargles (SSN 0.9%). Receives: Drug: Placebo |
| Experimental | Experimental | Health personnel who work in higher risk places (hospitals and primary level consultation) with conventional protection elements added to the application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm). Receives: Drug: Stabilized hypochlorous acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of infection by COVID19
Number of participants who get COVID19 infection during the application of S-HClO
Measured: Through study completion, an average of 6 months
Secondary outcomes (4)
Adverse drug reaction (ADR)
Determine the occurrence of ADR by the use of S-HClO
Measured: Through study completion, an average of 6 months
Seroconversion
Determine the frequency of seroconversion due to COVID 19
Measured: Through study completion, an average of 6 months
Hospitalization
Number of participants who fell ill from COVID-19 and was not hospitalized
Measured: Through study completion, an average of 6 months
ICU
Number of participants who fell ill from COVID-19 and was hospitalized in ICU
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start15 Feb 2021 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Why it stopped: The study did not achieve funding or approval by the ethics committee. Once the vaccination phase was entered, the study lost validity and was not viable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-masked, placebo-controlled clinical experiment is proposed.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Juan Zambrano, MD. M.Sc., Principal investigator, Hospital Universitario San Ignacio/Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684550
- Sponsor's protocol ID
- FM-CIE-0824-20
- Status last verified
- Mar 2023
- First submitted
- 21 Dec 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hui DS, Chan PK. Severe acute respiratory syndrome and coronavirus. Infect Dis Clin North Am. 2010 Sep;24(3):619-38. doi: 10.1016/j.idc.2010.04.009.
PubMed 20674795Velavan TP, Meyer CG. The COVID-19 epidemic. Trop Med Int Health. 2020 Mar;25(3):278-280. doi: 10.1111/tmi.13383. Epub 2020 Feb 16. No abstract available.
PubMed 32052514Gold MH, Andriessen A, Bhatia AC, Bitter P Jr, Chilukuri S, Cohen JL, Robb CW. Topical stabilized hypochlorous acid: The future gold standard for wound care and scar management in dermatologic and plastic surgery procedures. J Cosmet Dermatol. 2020 Feb;19(2):270-277. doi: 10.1111/jocd.13280. Epub 2020 Jan 6.
PubMed 31904191Hakim H, Thammakarn C, Suguro A, Ishida Y, Kawamura A, Tamura M, Satoh K, Tsujimura M, Hasegawa T, Takehara K. Evaluation of sprayed hypochlorous acid solutions for their virucidal activity against avian influenza virus through in vitro experiments. J Vet Med Sci. 2015 Feb;77(2):211-5. doi: 10.1292/jvms.14-0413. Epub 2014 Nov 24.
PubMed 25421399Taharaguchi M, Takimoto K, Zamoto-Niikura A, Yamada YK. Effect of weak acid hypochlorous solution on selected viruses and bacteria of laboratory rodents. Exp Anim. 2014;63(2):141-7. doi: 10.1538/expanim.63.141.
PubMed 24770639Ishihara M, Murakami K, Fukuda K, Nakamura S, Kuwabara M, Hattori H, Fujita M, Kiyosawa T, Yokoe H. Stability of Weakly Acidic Hypochlorous Acid Solution with Microbicidal Activity. Biocontrol Sci. 2017;22(4):223-227. doi: 10.4265/bio.22.223.
PubMed 29279579Edward DG, Lidwell OM. Studies on air-borne virus infections: III. The killing of aerial suspensions of influenza virus by hypochlorous acid. J Hyg (Lond). 1943 Sep;43(3):196-200. doi: 10.1017/s002217240001281x. No abstract available.
PubMed 20475674Yu MS, Kim BH, Kang SH, Lim DJ. Low-concentration hypochlorous acid nasal irrigation for chronic sinonasal symptoms: a prospective randomized placebo-controlled study. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1527-1533. doi: 10.1007/s00405-016-4387-5. Epub 2016 Nov 17.
PubMed 27853946
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study (RCT) Phase 3 of the Safety and Efficacy of Hypochlorous Acid in the Prophylaxis of Healthcare Personnel at High Risk of Infection by SARS-CoV2 (COVID19) Versus Placebo
- ClinicalTrials.gov ID
- NCT04684550
- Acronym / sponsor ID
- FM-CIE-0824-20
- Conditions
- SARS-CoV Infection, Covid19, Infection Viral
- Keywords
- SARS-CoV Infection, Stabilized hypochlorous acid (S-HClO), Prophylaxis, Health Professionals
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not achieve funding or approval by the ethics committee. Once the vaccination phase was entered, the study lost validity and was not viable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 24 Dec 2020 (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 pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. This requires a coordinated, effective and immediate action on the part of governments, companies, academic entities and even at the individual level.
In the search for new therapeutic and prevention alternatives, the application of hypochlorous acid (HClO) to the nasal mucosa is proposed, a broad-spectrum and fast-acting antimicrobial solution, whose safety has been proven in preclinical trials. The efficacy of HClO has been tested against enveloped and non-enveloped viruses, reducing virus particles without affecting human cells. This solution could contribute to reducing the viral load and the risk of contamination of patients and professionals. This could have an impact on controlling the COVID-19 pandemic.
Detailed description
Hypochlorous acid (HClO) is a powerful antimicrobial and antiviral used for the control of various infections, repair and washing of surgical wounds, as well as for disinfection of surfaces. In vivo, it is synthesized by the cells of the immune system for the control of pathogens during phagocytosis and has been synthesized and stabilized for use in different entities.
The therapeutic uses of HClO began in the First World War with the studies of Alexis Carrel and Henry Dakin who obtained a buffered sodium hypochlorite solution (Dakin's solution) which generated ideal concentrations of HClO, using it successfully in washing and treatment of wounds without presenting any damage or undesired effect on the patient's tissues. In 1993, the HClO molecule was stabilized, popularizing its use for the control of predominantly skin infections, treatment of chronic ulcers, closure and cleaning of wounds, management of burned patients, and disinfection of surfaces.
Biologically, it is part of the reactive oxygen species (ROS) synthesized by cells of the immune system (Neutrophils and Macrophages) during an immunological process known as "respiratory burst", during phagocytosis of antigens in reaction with the enzyme myeloperoxidase (MPO), hydrogen peroxide (H2O2) and a chlorine ion. Safety profiles in in vivo models have driven our initiative to use Stabilized Hypochlorous Acid (S-HClO), as an early therapeutic option in patients with SARS-Cov-2 infection or in close contact with COVID-193 positive patients.
Calderon et al and carried out the evaluation of the antimicrobial effect of HClO on potentially pathogenic microorganisms of the oral cavity. The study reports that hypochlorous acid achieved bacterial inhibition of 99.9% at a concentration of 0.05% and a pH of 5.2 per minute of action for different types of bacteria and for infectious microorganisms. Virological tests have also been performed on feline calcivirus (Ebola-like virus), rotavirus, AH1N1, adenovirus and SARS, found to be highly effective after 1 minute of application.
In the face of the COVID-19 pandemic, effective and early treatments are being sought to help prevent the dissipation of the virus (disinfection of surfaces), to neutralize the virus at an early stage when it is lodged in the upper respiratory tract and nose, since this is the Probable route of infection of the ethmoid lamina and later causing viral encephalopathy and treatment of patients with bronchial infection by this virus, decreasing the viral load and causing destruction of the virus. There are reports of the use of HClO in the nasal mucosa in studies in humans, reporting safety and effectiveness, both in adults and in children, which leads us to propose the application of said nasal spray solution, as a prophylaxis in health personnel with a high risk of infection by SARS-CoV-2.
A RCT with the use S-HClO as a prevention treatment for the infection by SARS-CoV-2 in health professionals is proposed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-masked, placebo-controlled clinical experiment is proposed.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboHealth personnel who work in places of greater risk (hospitals and primary level consultation) with conventional protection elements added to the application of 2 nasal puff every 8 hours of a nasal spray containing 0.9% SSN (placebo) and gargles (SSN 0.9%). |
| Experimental | Experimental | Drug: Stabilized hypochlorous acidHealth personnel who work in higher risk places (hospitals and primary level consultation) with conventional protection elements added to the application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Specialist physicians, resident physicians, medical students, and nursing personnel who work at the San Ignacio University Hospital.
- Subjects of any sex over 18 years of age who work as health care personnel, in care services that care for patients with a suspected or confirmed diagnosis of COVID-19 and who are active during the study recruitment.
- That they have not presented general symptoms such as malaise, fever, cough, dyspnea or muscle pain during the last 7 days.
- Subjects negative to the antigen test for COVID-19.
Key exclusion criteria (7 listed)
- Subjects considered as a resolved case of COVID-19 infection, according to guidelines from the Colombian National Institute of Health.
- Health personnel with social distancing due to close contact without personal protective equipment with patients confirmed to be infected or taking any medication as a possible prophylaxis for COVID-19 (example: chloroquine, hydroxychloroquine, azithromycin)
- Health workers who have permits or temporary withdrawal from their hospital work for more than one week during the month of the study.
- Some type of allergy to chlorinated agents or hypersensitivity to HClO
- Known diagnosis of upper airway respiratory disease where COVID-19 such as the common cold, sinusitis, pharyngitis, laryngotracheitis and epiglottitis or lower such as bronchiolitis, pneumonia, and mixed conditions have been ruled out.
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 |
|---|---|---|
| Stabilized hypochlorous acidApplication of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm). | Drug | Experimental |
| PlaceboApplication of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm). | Drug | Placebo |
Primary outcome
Prevention of infection by COVID19
Time frame: Through study completion, an average of 6 months
Number of participants who get COVID19 infection during the application of S-HClO
4 secondary outcomes
Adverse drug reaction (ADR)
Time frame: Through study completion, an average of 6 months
Seroconversion
Time frame: Through study completion, an average of 6 months
Hospitalization
Time frame: Through study completion, an average of 6 months
ICU
Time frame: Through study completion, an average of 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 20674795Hui DS, Chan PK. Severe acute respiratory syndrome and coronavirus. Infect Dis Clin North Am. 2010 Sep;24(3):619-38. doi: 10.1016/j.idc.2010.04.009.
- Background: PubMed 32052514Velavan TP, Meyer CG. The COVID-19 epidemic. Trop Med Int Health. 2020 Mar;25(3):278-280. doi: 10.1111/tmi.13383. Epub 2020 Feb 16. No abstract available.
- Background: PubMed 31904191Gold MH, Andriessen A, Bhatia AC, Bitter P Jr, Chilukuri S, Cohen JL, Robb CW. Topical stabilized hypochlorous acid: The future gold standard for wound care and scar management in dermatologic and plastic surgery procedures. J Cosmet Dermatol. 2020 Feb;19(2):270-277. doi: 10.1111/jocd.13280. Epub 2020 Jan 6.
- Background: PubMed 25421399Hakim H, Thammakarn C, Suguro A, Ishida Y, Kawamura A, Tamura M, Satoh K, Tsujimura M, Hasegawa T, Takehara K. Evaluation of sprayed hypochlorous acid solutions for their virucidal activity against avian influenza virus through in vitro experiments. J Vet Med Sci. 2015 Feb;77(2):211-5. doi: 10.1292/jvms.14-0413. Epub 2014 Nov 24.
- Background: PubMed 24770639Taharaguchi M, Takimoto K, Zamoto-Niikura A, Yamada YK. Effect of weak acid hypochlorous solution on selected viruses and bacteria of laboratory rodents. Exp Anim. 2014;63(2):141-7. doi: 10.1538/expanim.63.141.
- Background: PubMed 29279579Ishihara M, Murakami K, Fukuda K, Nakamura S, Kuwabara M, Hattori H, Fujita M, Kiyosawa T, Yokoe H. Stability of Weakly Acidic Hypochlorous Acid Solution with Microbicidal Activity. Biocontrol Sci. 2017;22(4):223-227. doi: 10.4265/bio.22.223.
- Background: PubMed 20475674Edward DG, Lidwell OM. Studies on air-borne virus infections: III. The killing of aerial suspensions of influenza virus by hypochlorous acid. J Hyg (Lond). 1943 Sep;43(3):196-200. doi: 10.1017/s002217240001281x. No abstract available.
- Background: PubMed 27853946Yu MS, Kim BH, Kang SH, Lim DJ. Low-concentration hypochlorous acid nasal irrigation for chronic sinonasal symptoms: a prospective randomized placebo-controlled study. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1527-1533. doi: 10.1007/s00405-016-4387-5. Epub 2016 Nov 17.
- 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.
Juan Zambrano, MD. M.Sc. principal investigator
Hospital Universitario San Ignacio/Pontificia Universidad Javeriana
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Stabilized hypochlorous acid in people with SARS-CoV Infection and Covid19, run by Hospital Universitario San Ignacio.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Prevention of infection by COVID19 (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04684550, which also lists 8 linked publications.
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 3 Mar 2023.