Covid19Phase 1RUNCT04700163

RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers

A Phase 1 study testing C144-LS and C-135-LS in people with Covid19, run by Rockefeller University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a first-in-human, open label, single dose, dose-escalation phase 1 study to evaluate the safety and pharmacokinetics of a combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein in healthy… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: C144-LS and C-135-LS
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 11 Jan 2021to 2 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 18 or older.
If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use one effective method of contraception from 10 days prior to the antibody administration until 6 months after investigational product (IP) administration.

Who cannot join

Weight > 110 kg for groups S1 and S2 only
History of prior positive SARS-CoV-2 RT-PCR or SARS-CoV-2 serology.
Active respiratory or non-respiratory symptoms consistent with COVID-19.
Medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening.
Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations, or uncontrolled hypertension, as defined by a systolic blood pressure > 180 and/or diastolic blood pressure > 120, in the presence or absence of anti-hypertensive medications) in the past 6 months prior to screening.
Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months.

Show all 20Show fewer

Other clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.
Laboratory abnormalities in the parameters listed:
Absolute neutrophil count less than 1,500 K/mcL;
Hemoglobin less than 10.5 gm/dL if female; less than 11 gm/dL if male;
Platelet count less than 125,000 K/mcL;
ALT less than 1.25 x ULN; AST less than 1.25 x ULN;
Total bilirubin less than 1.25 x ULN;
Creatinine less than 1.1 x ULN;
Pregnancy or lactation.
Any vaccination within 14 days prior to SARS-CoV-2 mAbs administration (except influenza vaccine).
History of prior receipt of any SARS-CoV-2 vaccine or antibodies, including convalescent plasma.
Known allergy/sensitivity or any hypersensitivity to components of the investigational agents.
History of severe reaction to a vaccine or monoclonal antibody administration or history of severe allergic reactions.
Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Rockefeller University
New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 1, Open Label, Dose-escalation Study of the Safety and Pharmacokinetics of a Combination of Two Anti-SARS-CoV-2 mAbs (C144-LS and C135-LS) in Healthy Volunteers

Read the detailed description

The study has a standard 3+3 phase 1 dose escalation design. Study participants will receive subcutaneous injections of C144-LS and C135-LS at 4ml (approximately 100mg of each antibody administered separately) or 8ml (approximately 200mg of each antibody administered separately), or sequential intravenous infusions of C144-LS and C135-LS, at one of three increasing dose levels (1.5 mg/kg, 5 mg/kg and 15 mg/kg of each antibody).

Conditions: Covid19
Being tested: C144-LS and C-135-LS
Keywords: Monoclonal antibody, 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.

C144-LS and C-135-LSBiological
A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein

Study groups in NCT04700163
Study group	Role	What they receive
S1 - low dose	Experimental	100 mg of C144-LS and 100 mg of C135-LS, subcutaneously Receives: Biological: C144-LS and C-135-LS
S2 - mid dose	Experimental	200 mg of C144-LS and 200 mg of C135-LS, subcutaneously Receives: Biological: C144-LS and C-135-LS
V1 - low dose	Experimental	1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously Receives: Biological: C144-LS and C-135-LS
V2 - mid dose	Experimental	5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously Receives: Biological: C144-LS and C-135-LS
V3 - high dose	Experimental	15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously Receives: Biological: C144-LS and C-135-LS

What is being measured

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

Grade 2 and Higher Adverse Events 4 Weeks After Administration.
The number of participants with treatment-related solicited and unsolicited grade 2 adverse events (including confirmed laboratory abnormalities).
Measured: 4 weeks
Grade 3 and Higher Adverse Events 4 Weeks After Administration.
The number of participants with treatment-related solicited and unsolicited grade 3 adverse events (including confirmed laboratory abnormalities).
Measured: 4 weeks
Related Serious Adverse Events (SAEs) Throughout the Study Period
The number of participants with treatment-related solicited serious adverse events.
Measured: 48 weeks
Elimination Half-life (t1/2) of C135-LS and C144-LS
Half-life of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Measured: 48 weeks
Clearance Rate of C135-LS and C144-LS
Clearance rate of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Measured: 48 weeks
Area Under the Curve of C135-LS and C144-LS
Area under the curve of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Measured: 48 weeks

Secondary outcomes (2)

Investigational Product (IP)-Related Adverse Events During Study Follow up.
The number of participants with treatment-related adverse events
Measured: 48 weeks
Anti-C144-LS and Anti-C135-LS Antibodies in All Study Groups.
Proportion of individuals with treatment-induced anti-drug antibodies against each mAb and magnitude of the response
Measured: 48 weeks

Timeline

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

11 Jan 20212 Feb 2022

First posted7 Jan 2021
Study start11 Jan 2021
Primary completion2 Feb 2022
Study completion2 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)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: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04700163
Sponsor's protocol ID: RUCOV1
Other IDs: CGA-1015
Acronym: RU
Status last verified: Mar 2025
First submitted: 5 Jan 2021
Last updated: 13 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Schafer A, Muecksch F, Lorenzi JCC, Leist SR, Cipolla M, Bournazos S, Schmidt F, Maison RM, Gazumyan A, Martinez DR, Baric RS, Robbiani DF, Hatziioannou T, Ravetch JV, Bieniasz PD, Bowen RA, Nussenzweig MC, Sheahan TP. Antibody potency, effector function, and combinations in protection and therapy for SARS-CoV-2 infection in vivo. J Exp Med. 2021 Mar 1;218(3):e20201993. doi: 10.1084/jem.20201993.
PubMed 33211088
Weisblum Y, Schmidt F, Zhang F, DaSilva J, Poston D, Lorenzi JC, Muecksch F, Rutkowska M, Hoffmann HH, Michailidis E, Gaebler C, Agudelo M, Cho A, Wang Z, Gazumyan A, Cipolla M, Luchsinger L, Hillyer CD, Caskey M, Robbiani DF, Rice CM, Nussenzweig MC, Hatziioannou T, Bieniasz PD. Escape from neutralizing antibodies by SARS-CoV-2 spike protein variants. Elife. 2020 Oct 28;9:e61312. doi: 10.7554/eLife.61312.
PubMed 33112236
Barnes CO, Jette CA, Abernathy ME, Dam KA, Esswein SR, Gristick HB, Malyutin AG, Sharaf NG, Huey-Tubman KE, Lee YE, Robbiani DF, Nussenzweig MC, West AP Jr, Bjorkman PJ. SARS-CoV-2 neutralizing antibody structures inform therapeutic strategies. Nature. 2020 Dec;588(7839):682-687. doi: 10.1038/s41586-020-2852-1. Epub 2020 Oct 12.
PubMed 33045718
Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, Agudelo M, Barnes CO, Gazumyan A, Finkin S, Hagglof T, Oliveira TY, Viant C, Hurley A, Hoffmann HH, Millard KG, Kost RG, Cipolla M, Gordon K, Bianchini F, Chen ST, Ramos V, Patel R, Dizon J, Shimeliovich I, Mendoza P, Hartweger H, Nogueira L, Pack M, Horowitz J, Schmidt F, Weisblum Y, Michailidis E, Ashbrook AW, Waltari E, Pak JE, Huey-Tubman KE, Koranda N, Hoffman PR, West AP Jr, Rice CM, Hatziioannou T, Bjorkman PJ, Bieniasz PD, Caskey M, Nussenzweig MC. Convergent antibody responses to SARS-CoV-2 in convalescent individuals. Nature. 2020 Aug;584(7821):437-442. doi: 10.1038/s41586-020-2456-9. Epub 2020 Jun 18.
PubMed 32555388
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343

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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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open Label, Dose-escalation Study of the Safety and Pharmacokinetics of a Combination of Two Anti-SARS-CoV-2 mAbs (C144-LS and C135-LS) in Healthy Volunteers
ClinicalTrials.gov ID: NCT04700163
Acronym / sponsor ID: RU / RUCOV1
Conditions: Covid19
Keywords: Monoclonal antibody, SARS-CoV-2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Rockefeller UniversityUniversity, hospital or other
Study start: 11 Jan 2021 (actual)
Primary completion: 2 Feb 2022 (actual)
Study completion: 2 Feb 2022 (actual)
First posted: 7 Jan 2021 (actual)
Results: Posted 13 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
S1 - low dose	Experimental	Biological: C144-LS and C-135-LS100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
S2 - mid dose	Experimental	Biological: C144-LS and C-135-LS200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
V1 - low dose	Experimental	Biological: C144-LS and C-135-LS1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
V2 - mid dose	Experimental	Biological: C144-LS and C-135-LS5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
V3 - high dose	Experimental	Biological: C144-LS and C-135-LS15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Aged 18 or older.
If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use one effective method of contraception from 10 days prior to the antibody administration until 6 months after investigational product (IP) administration.

Key exclusion criteria (20 listed)

Weight > 110 kg for groups S1 and S2 only
History of prior positive SARS-CoV-2 RT-PCR or SARS-CoV-2 serology.
Active respiratory or non-respiratory symptoms consistent with COVID-19.
Medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening.
Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations, or uncontrolled hypertension, as defined by a systolic blood pressure > 180 and/or diastolic blood pressure > 120, in the presence or absence of anti-hypertensive medications) in the past 6 months prior to screening.

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
C144-LS and C-135-LSA combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein	Biological	S1 - low dose, S2 - mid dose, V1 - low dose, V2 - mid dose, V3 - high dose

Primary outcome

Grade 2 and Higher Adverse Events 4 Weeks After Administration.
Time frame: 4 weeks
The number of participants with treatment-related solicited and unsolicited grade 2 adverse events (including confirmed laboratory abnormalities).
Grade 3 and Higher Adverse Events 4 Weeks After Administration.
Time frame: 4 weeks
The number of participants with treatment-related solicited and unsolicited grade 3 adverse events (including confirmed laboratory abnormalities).
Related Serious Adverse Events (SAEs) Throughout the Study Period
Time frame: 48 weeks
The number of participants with treatment-related solicited serious adverse events.
Elimination Half-life (t1/2) of C135-LS and C144-LS
Time frame: 48 weeks
Half-life of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Clearance Rate of C135-LS and C144-LS
Time frame: 48 weeks
Clearance rate of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Area Under the Curve of C135-LS and C144-LS
Time frame: 48 weeks
Area under the curve of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers

2 secondary outcomes

Investigational Product (IP)-Related Adverse Events During Study Follow up.
Time frame: 48 weeks
Anti-C144-LS and Anti-C135-LS Antibodies in All Study Groups.
Time frame: 48 weeks

Results and safety

Results posted to the registry on 13 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
S1 - Low Dose	3	3
S2 - Mid Dose	3	3
V1 - Low Dose	3	3
V2 - Mid Dose	3	3
V3 - High Dose	3	3
S3 - Open Label	8	7

Primary outcome: Grade 2 and Higher Adverse Events 4 Weeks After Administration.

Time frame: 4 weeks. Count of participants. Unit: Participants

Measure	S1 - Low Dose n = 3	S2 - Mid Dose n = 3	V1 - Low Dose n = 3	V2 - Mid Dose n = 3	V3 - High Dose n = 3	S3 - Open Label n = 8
Value	0	0	0	0	0	0

Primary outcome: Grade 3 and Higher Adverse Events 4 Weeks After Administration.

Time frame: 4 weeks. Count of participants. Unit: Participants

Measure	S1 - Low Dose n = 3	S2 - Mid Dose n = 3	V1 - Low Dose n = 3	V2 - Mid Dose n = 3	V3 - High Dose n = 3	S3 - Open Label n = 8
Value	0	0	0	0	0	0

Primary outcome: Related Serious Adverse Events (SAEs) Throughout the Study Period

Time frame: 48 weeks. Count of participants. Unit: Participants

Measure	S1 - Low Dose n = 3	S2 - Mid Dose n = 3	V1 - Low Dose n = 3	V2 - Mid Dose n = 3	V3 - High Dose n = 3	S3 - Open Label n = 8
Value	0	0	0	0	0	0

Primary outcome: Elimination Half-life (t1/2) of C135-LS and C144-LS

Time frame: 48 weeks. Mean (Standard Deviation). Unit: days

Measure	S1 - Low Dose n = 3	S2 - Mid Dose n = 3	V1 - Low Dose n = 3	V2 - Mid Dose n = 3	V3 - High Dose n = 3	S3 - Open Label n = 7
C135-LS Half-life	79.85 (10.84)	89.55 (17.06)	90.79 (15.11)	91.91 (12.57)	96.24 (13.56)	89.55 (17.06)
C144-LS Half-life	80.96 (14.58)	107.3 (29.21)	96.37 (11.48)	114.4 (3.444)	103.5 (14.10)	107.3 (29.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
S1 - Low Dose	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
S2 - Mid Dose	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
V1 - Low Dose	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
V2 - Mid Dose	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
V3 - High Dose	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
S3 - Open Label	0 of 8 (0%)	2 of 8 (25%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33211088Schafer A, Muecksch F, Lorenzi JCC, Leist SR, Cipolla M, Bournazos S, Schmidt F, Maison RM, Gazumyan A, Martinez DR, Baric RS, Robbiani DF, Hatziioannou T, Ravetch JV, Bieniasz PD, Bowen RA, Nussenzweig MC, Sheahan TP. Antibody potency, effector function, and combinations in protection and therapy for SARS-CoV-2 infection in vivo. J Exp Med. 2021 Mar 1;218(3):e20201993. doi: 10.1084/jem.20201993.
Background: PubMed 33112236Weisblum Y, Schmidt F, Zhang F, DaSilva J, Poston D, Lorenzi JC, Muecksch F, Rutkowska M, Hoffmann HH, Michailidis E, Gaebler C, Agudelo M, Cho A, Wang Z, Gazumyan A, Cipolla M, Luchsinger L, Hillyer CD, Caskey M, Robbiani DF, Rice CM, Nussenzweig MC, Hatziioannou T, Bieniasz PD. Escape from neutralizing antibodies by SARS-CoV-2 spike protein variants. Elife. 2020 Oct 28;9:e61312. doi: 10.7554/eLife.61312.
Background: PubMed 33045718Barnes CO, Jette CA, Abernathy ME, Dam KA, Esswein SR, Gristick HB, Malyutin AG, Sharaf NG, Huey-Tubman KE, Lee YE, Robbiani DF, Nussenzweig MC, West AP Jr, Bjorkman PJ. SARS-CoV-2 neutralizing antibody structures inform therapeutic strategies. Nature. 2020 Dec;588(7839):682-687. doi: 10.1038/s41586-020-2852-1. Epub 2020 Oct 12.
Results publication: PubMed 32555388Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, Agudelo M, Barnes CO, Gazumyan A, Finkin S, Hagglof T, Oliveira TY, Viant C, Hurley A, Hoffmann HH, Millard KG, Kost RG, Cipolla M, Gordon K, Bianchini F, Chen ST, Ramos V, Patel R, Dizon J, Shimeliovich I, Mendoza P, Hartweger H, Nogueira L, Pack M, Horowitz J, Schmidt F, Weisblum Y, Michailidis E, Ashbrook AW, Waltari E, Pak JE, Huey-Tubman KE, Koranda N, Hoffman PR, West AP Jr, Rice CM, Hatziioannou T, Bjorkman PJ, Bieniasz PD, Caskey M, Nussenzweig MC. Convergent antibody responses to SARS-CoV-2 in convalescent individuals. Nature. 2020 Aug;584(7821):437-442. doi: 10.1038/s41586-020-2456-9. Epub 2020 Jun 18.
Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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.

Christian Gaebler, MD principal investigator

The Rockefeller University

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing C144-LS and C-135-LS in people with Covid19, run by Rockefeller University at 1 site in United States.

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 2 inclusion and 20 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 13 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 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?

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.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Grade 2 and Higher Adverse Events 4 Weeks After Administration. (time frame: 4 weeks). The study lists 6 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 NCT04700163, which also lists 5 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 13 Mar 2025.