Covid19Early Phase 1COVSP-BCGNCT03305341

Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix

A Early Phase 1 study testing COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use in people with Covid19, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers. 1. Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains. 2. Read more about this study

Who is it for?: Ages 24 to 64 years
Conditions the study is for: Covid19
What is being tested?: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 18 May 2025to 28 Dec 2026
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

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 24 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Controlled Cancers
Moderate COVID-19
Positive testing by standard RT-PCR assay or equivalent testing
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
No clinical signs indicative of Severe or Critical Illness Severity

Who cannot join

1. Uncontrolled Cancers
2. Severe or Critical Illness Severity
3. Pregnancy
4. Breast-feeding
5. The patients with other serious inter-current illness
6. Serious Allergy
7. Serious Bleed Tendency
8. The prohibition of the biological product

Trial locations and contacts

1 site in 1 country.

United States1 site

Medicine Invention Design Incorporation (MIDI) - IORG0007849
North Bethesda, Maryland, 20852

Other trials in United States

About this study

Official title: Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients With Controlled Cancers.

Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.
Activate Human Antigen Presentation Reaction to COVID-19 Specific Antigen.
The human antigen presenting cells (APCs) can take up and process COVID-19 target antigen protein into small peptide fragments, and then COVID-19 virus can be killed by APCs directly.

Read the detailed description

Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers.
20 Moderate COVID-19 patients with controlled cancers
Moderate COVID-19
Positive testing by standard RT-PCR assay or equivalent testing
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
No clinical signs indicative of Severe or Critical Illness Severity
Novavax COVID-19 Vaccine 1.0 mL plus BCG Organism 50 MG Mix
By the percutaneous route with the multiple puncture device
Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 3 weeks.
Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days.
Our trial duration will be 4 weeks.

Conditions: Covid19
Being tested: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
Keywords: Gene Mutation, Antigen Presentation, APC, Spike, COVID-19
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous useBiological
Also called NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix
- By the percutaneous route with the multiple puncture device
- NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix

Study groups in NCT03305341
Study group	Role	What they receive
Assess for therapeutic biologics activity (proof-of-concept)	Experimental	Therapeutic Biological Product Mix activity - NOVAVAX COVID-19 VACCINE 1.0 mL add into BCG Organism 50 MG Receives: Biological: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Moderate COVID-19:
- 20 Moderate COVID-19 patients with controlled cancers
- Moderate COVID-19
- Positive testing by standard RT-PCR assay
- Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
- Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
- No clinical signs indicative of Severe or Critical Illness Severity
Measured: Duration at least 28 days
Rate of Positive COVID-19 nucleic acid:
- 20 Moderate COVID-19 patients with controled cancers
- Positive testing COVID-19 by standard RT-PCR assay immediately
- COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit
- Rate of Positive COVID-19 nucleic acid must be 100%
Measured: Duration at least 28 days
Rate of Negative COVID-19 nucleic acid
- 20 Moderate COVID-19 patients with controlled cancers
- NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix
- By the percutaneous route with the multiple puncture device
- Negative COVID-19 by standard RT-PCR assay after percutaneous use 3 weeks
- COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit
- Rate of Negative COVID-19 nucleic acid will be more than 80%
Measured: Duration at least 28 days
20 COVID-19 Participants with IGRA blood test with COVID-19 spike protein antigen
Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days
Measured: Duration at least 28 days
20 COVID-19 Participants with IGRA blood test with TB antigens
- Negative IGRA blood test with TB antigens before percutaneous use
- Positive IGRA blood test with TB antigens after percutaneous use 21 days
Measured: Duration at least 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202528 Dec 2026

First posted9 Oct 2017
Study start18 May 2025
Primary completion18 Nov 2026 (estimated)
Study completion28 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Covid19Studies 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: Early Phase 1
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: Single Usage / Single Dosage
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03305341
Sponsor's protocol ID: IND165646
Other IDs: FWA00015357, IRB00009424, IORG0007849, NPI-1831468511, NPI-1023387701, IND165646
Acronym: COVSP-BCG
Status last verified: Jun 2026
First submitted: 4 Oct 2017
Last updated: 10 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.
PubMed 27102489
Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
PubMed 32132681
Sanchez-Ramon S, Conejero L, Netea MG, Sancho D, Palomares O, Subiza JL. Trained Immunity-Based Vaccines: A New Paradigm for the Development of Broad-Spectrum Anti-infectious Formulations. Front Immunol. 2018 Dec 17;9:2936. doi: 10.3389/fimmu.2018.02936. eCollection 2018.
PubMed 30619296
Guevara-Hoyer K, Saz-Leal P, Diez-Rivero CM, Ochoa-Grullon J, Fernandez-Arquero M, Perez de Diego R, Sanchez-Ramon S. Trained Immunity Based-Vaccines as a Prophylactic Strategy in Common Variable Immunodeficiency. A Proof of Concept Study. Biomedicines. 2020 Jul 9;8(7):203. doi: 10.3390/biomedicines8070203.
PubMed 32660100
Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020 Dec 10;383(24):2320-2332. doi: 10.1056/NEJMoa2026920. Epub 2020 Sep 2.
PubMed 32877576
Wollina U. Challenges of COVID-19 pandemic for dermatology. Dermatol Ther. 2020 Sep;33(5):e13430. doi: 10.1111/dth.13430. Epub 2020 Apr 30.
PubMed 32314460
Catala Gonzalo A, Galvan Casas C. COVID-19 and the Skin. Actas Dermosifiliogr (Engl Ed). 2020 Jul-Aug;111(6):447-449. doi: 10.1016/j.ad.2020.04.007. Epub 2020 May 13. No abstract available. English, Spanish.
PubMed 32401723
Guarneri C, Rullo EV, Pavone P, Berretta M, Ceccarelli M, Natale A, Nunnari G. Silent COVID-19: what your skin can reveal. Lancet Infect Dis. 2021 Jan;21(1):24-25. doi: 10.1016/S1473-3099(20)30402-3. Epub 2020 May 18. No abstract available.
PubMed 32437697
Freeman EE, McMahon DE, Lipoff JB, Rosenbach M, Kovarik C, Takeshita J, French LE, Thiers BH, Hruza GJ, Fox LP; American Academy of Dermatology Ad Hoc Task Force on COVID-19. Pernio-like skin lesions associated with COVID-19: A case series of 318 patients from 8 countries. J Am Acad Dermatol. 2020 Aug;83(2):486-492. doi: 10.1016/j.jaad.2020.05.109. Epub 2020 May 30.
PubMed 32479979

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients With Controlled Cancers.
ClinicalTrials.gov ID: NCT03305341
Acronym / sponsor ID: COVSP-BCG / IND165646
Conditions: Covid19
Keywords: Gene Mutation, Antigen Presentation, APC, Spike, COVID-19
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairIndustry (pharma, biotech, devices)
Collaborators: UnitedHealthcare
Study start: 18 May 2025 (actual)
Primary completion: 18 Nov 2026 (estimated)
Study completion: 28 Dec 2026 (estimated)
First posted: 9 Oct 2017 (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.

Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.
Activate Human Antigen Presentation Reaction to COVID-19 Specific Antigen.
The human antigen presenting cells (APCs) can take up and process COVID-19 target antigen protein into small peptide fragments, and then COVID-19 virus can be killed by APCs directly.

Detailed description

Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers.
20 Moderate COVID-19 patients with controlled cancers
Moderate COVID-19
Positive testing by standard RT-PCR assay or equivalent testing
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
No clinical signs indicative of Severe or Critical Illness Severity
Novavax COVID-19 Vaccine 1.0 mL plus BCG Organism 50 MG Mix
By the percutaneous route with the multiple puncture device
Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 3 weeks.
Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days.
Our trial duration will be 4 weeks.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Usage / Single Dosage

Arm	Type	Receives
Assess for therapeutic biologics activity (proof-of-concept)	Experimental	Biological: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous useTherapeutic Biological Product Mix activity - NOVAVAX COVID-19 VACCINE 1.0 mL add into BCG Organism 50 MG

Who may qualify

Ages: 24 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Controlled Cancers
Moderate COVID-19
Positive testing by standard RT-PCR assay or equivalent testing
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute

Key exclusion criteria (8 listed)

1. Uncontrolled Cancers
2. Severe or Critical Illness Severity
3. Pregnancy
4. Breast-feeding
5. The patients with other serious inter-current illness

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
COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous useAlso: NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix* By the percutaneous route with the multiple puncture device * NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix	Biological	Assess for therapeutic biologics activity (proof-of-concept)

Primary outcome

Number of Participants with Moderate COVID-19:
Time frame: Duration at least 28 days
* 20 Moderate COVID-19 patients with controlled cancers * Moderate COVID-19 * Positive testing by standard RT-PCR assay * Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion * Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute * No clinical signs indicative of Severe or Critical Illness Severity
Rate of Positive COVID-19 nucleic acid:
Time frame: Duration at least 28 days
* 20 Moderate COVID-19 patients with controled cancers * Positive testing COVID-19 by standard RT-PCR assay immediately * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Positive COVID-19 nucleic acid must be 100%
Rate of Negative COVID-19 nucleic acid
Time frame: Duration at least 28 days
* 20 Moderate COVID-19 patients with controlled cancers * NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix * By the percutaneous route with the multiple puncture device * Negative COVID-19 by standard RT-PCR assay after percutaneous use 3 weeks * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Negative COVID-19 nucleic acid will be more than 80%
20 COVID-19 Participants with IGRA blood test with COVID-19 spike protein antigen
Time frame: Duration at least 28 days
Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days
20 COVID-19 Participants with IGRA blood test with TB antigens
Time frame: Duration at least 28 days
* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
Background: PubMed 27102489Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.
Background: PubMed 32132681Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
Background: PubMed 30619296Sanchez-Ramon S, Conejero L, Netea MG, Sancho D, Palomares O, Subiza JL. Trained Immunity-Based Vaccines: A New Paradigm for the Development of Broad-Spectrum Anti-infectious Formulations. Front Immunol. 2018 Dec 17;9:2936. doi: 10.3389/fimmu.2018.02936. eCollection 2018.
Background: PubMed 32660100Guevara-Hoyer K, Saz-Leal P, Diez-Rivero CM, Ochoa-Grullon J, Fernandez-Arquero M, Perez de Diego R, Sanchez-Ramon S. Trained Immunity Based-Vaccines as a Prophylactic Strategy in Common Variable Immunodeficiency. A Proof of Concept Study. Biomedicines. 2020 Jul 9;8(7):203. doi: 10.3390/biomedicines8070203.
Background: PubMed 32877576Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020 Dec 10;383(24):2320-2332. doi: 10.1056/NEJMoa2026920. Epub 2020 Sep 2.
Background: PubMed 32314460Wollina U. Challenges of COVID-19 pandemic for dermatology. Dermatol Ther. 2020 Sep;33(5):e13430. doi: 10.1111/dth.13430. Epub 2020 Apr 30.
Background: PubMed 32401723Catala Gonzalo A, Galvan Casas C. COVID-19 and the Skin. Actas Dermosifiliogr (Engl Ed). 2020 Jul-Aug;111(6):447-449. doi: 10.1016/j.ad.2020.04.007. Epub 2020 May 13. No abstract available. English, Spanish.
Background: PubMed 32437697Guarneri C, Rullo EV, Pavone P, Berretta M, Ceccarelli M, Natale A, Nunnari G. Silent COVID-19: what your skin can reveal. Lancet Infect Dis. 2021 Jan;21(1):24-25. doi: 10.1016/S1473-3099(20)30402-3. Epub 2020 May 18. No abstract available.
Background: PubMed 32479979Freeman EE, McMahon DE, Lipoff JB, Rosenbach M, Kovarik C, Takeshita J, French LE, Thiers BH, Hruza GJ, Fox LP; American Academy of Dermatology Ad Hoc Task Force on COVID-19. Pernio-like skin lesions associated with COVID-19: A case series of 318 patients from 8 countries. J Am Acad Dermatol. 2020 Aug;83(2):486-492. doi: 10.1016/j.jaad.2020.05.109. Epub 2020 May 30.
FWA00015357Link provided by the sponsor.
IRB00009424Link provided by the sponsor.
IORG0007849Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

HAN XU, MD/PhD/FAPCR study chair

Medicine Invention Design, Inc. (MIDI) - IORG0007849

HAN XU, MD/PhD/FAPCR study director

Medicine Invention Design, Inc. (MIDI) - IORG0007849

HAN XU, MD/PhD/FAPCR principal investigator

Medicine Invention Design, Inc. (MIDI) - IORG0007849

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Number of Participants with Moderate COVID-19: (time frame: Duration at least 28 days). The study lists 5 primary outcomes in all. 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 NCT03305341, which also lists 9 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 10 Jun 2026.