COVID-19Phase 3NCT04516811
Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19
A Phase 3 study of COVID-19 and SARS-CoV-2 Infection, run by South African National Blood Service at 2 sites in South Africa.
Trial summary
A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection, Severe Acute Respiratory Syndrome Coronavirus 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 21 Sep 2020to 31 Jul 2022
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laboratory confirmed SARS-CoV-2 by positive RT-PCR on any respiratory sample;
- Age ≥ 18 years;
- Require hospital admission for COVID-19 pneumonia as defined by the presence of pulmonary infiltrates on chest x-ray;
- Moderate to severe Covid-19 disease, defined as: SpO2 ≤ 93% on room air; plus requiring non-invasive oxygen therapy (WHO R\&D BOSCI 4 or 5
- Signed informed consent;
- Pregnant women will be allowed to participate.
Who cannot join
- Current participation in another therapeutic clinical trial for COVID-19;
- Invasive mechanical ventilation;
- Expected survival < 24 hours based on clinical assessment (however, the study does not exclude critically ill patients who are not, due to resource limitations, candidates for critical care admission and/or mechanical ventilation);
- Known hypersensitivity to immunoglobulin or any components of the formulation;
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Universitas Hospital
Bloemfontein, Free State, 9301
Mitchells Plain Hospital
Cape Town, Western Cape, 7786
About this study
Official title: A Prospective, Randomized, Placebo-controlled, Double-blinded, Phase III Clinical Trial of the Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19
A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19
Read the detailed description
Full Title: A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19.
Short Title: PROTECT-Patient study
Aim: Assess the safety and efficacy of COVID-19 convalescent plasma (CCP) as a therapeutic treatment for hospitalised patients with moderate to severe COVID-19
Study Design: Randomised, double-blinded, placebo-controlled, phase III clinical trial
Intervention: Randomised 1:1 to either CCP plus standard of care (SOC) or to SOC plus placebo (200 mL normal saline)
Active Agent: A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.
Placebo: A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines
Sample Size: 600
Study Population: Consenting adult inpatients with moderate to severe COVID-19, not requiring invasive ventilation, who are admitted to a participating public or private sector hospital and who are not enrolled in another COVID-19 treatment trial.
Settings: Participating public and private sector hospitals in South Africa
- Being tested
- COVID-19 convalescent plasma (CCP) plus standard of care (SOC), Standard of care (SOC) plus placebo
- 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 convalescent plasma (CCP) plus standard of care (SOC)Biological
A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.
Standard of care (SOC) plus placeboBiological
A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines. Receives: Biological: COVID-19 convalescent plasma (CCP) plus standard of care (SOC) |
| Arm 2 | Placebo comparator | A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines. Receives: Biological: Standard of care (SOC) plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement
Proportion of participants with successful treatment outcome, defined as clinical improvement (≥ 2 points on WHO R\&D BOSCI 1) by Day 28 post-randomisation.
Measured: Day 28
Secondary outcomes (15)
Adverse Events of special interest
- Proportion of participants with adverse events of special interest (Transfusion-Associated Circulatory Overload (TACO); Transfusion-Related Acute Lung Injury (TRALI); allergic transfusion reaction).
Measured: Day 28
Serious Adverse Events
- Proportion of participants with serious adverse events.
Measured: Day 28
Survival
- Proportion of participants surviving at Day 28 post-randomisation.
Measured: Day 28
Invasive mechanical ventilation
- Proportion of participants requiring invasive mechanical ventilation.
Measured: Day 28
Disease severity
- Proportion of participants with moderate and severe ARDS.
Measured: Day 28
Time to outcomes of interest
- Time from randomization to death, clinical improvement, ICU admission, and invasive mechanical ventilation.
Measured: Day28
Length of stay meausures
- Duration of hospitalisation, ICU stay, and mechanical ventilation in survivors.
Measured: Day28
SARS-CoV PCR
- Proportion negative SARS-CoV-2 PCR at Day 28; time to viral clearance (PCR-negativity); change in SARS-CoV-2 PCR Ct value.
Measured: Day28
Inflammatory markers
- Proportion with and time to normalisation of inflammatory markers, including CRP, lymphocyte count, D-dimer, ferritin.
Measured: Day28
Radiography
- Worsening of radiographic abnormalities.
Measured: Day28
Fever & Hypoxia
- Proportion with and time to resolution of fever and hypoxia.
Measured: Day28
patients with HIV infection and other comorbidities
- Proportion of patients with HIV infection and other comorbidities (obesity, diabetes, hypertension) with primary efficacy outcome.
Measured: Day 28
Timing of IP & Efficacy Outcome
- Relationship between timing of transfusion from symptom onset and primary efficacy outcome.
Measured: Day 28
Neutralising Ab
- Relationship between convalescent plasma neutralizing antibody titers and primary efficacy outcome
Measured: Day28
SARS CoV Antibody titre
- Comparison of anti-SARS-CoV-2 titer dynamics between treatment arms
Measured: Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start21 Sep 2020
- Primary completion30 Dec 2021
- Study completion31 Jul 2022
Why it stopped: No benefit seen in 2 published inpatient RCTs (but had limitations). Press release from inpatient Recovery trial with large number of endpoints showed no benefit. CCP collected from survivors of original strain infection had no neutralisation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participant identification numbers (PIN), assigned at the screening/enrolment visit, will be used throughout the study. After signing the informed consent document, eligible participants will be randomised to one of the treatment arms, stratified by study site, age group (\<=65; \>65 years old) and body mass index (BMI) (\<30; \>=30 kg/m2). An electronic randomisation application will generate the treatment allocation. The trial Program Manager (PM), who will have no direct contact with trial participants or involvement in eligibility assessment or outcome assignment, will maintain the randomisation code.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- South African National Blood Service
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riana Cockeran, South African National Blood Service
- Investigators
- Sean Wasserman, A/Professor, Study chair, CIDRI-Africa, University of Cape TownKarin vandenBerg, Dr, Principal investigator, South African National Blood Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516811
- Sponsor's protocol ID
- PROTECT-Patient trial
- Status last verified
- May 2026
- First submitted
- 12 Aug 2020
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Where available and applicable, the results of this study will be reported to the appropriate scientific and management divisions of participating institutions. In addition, interim results may be communicated to lay press if doing so is deemed appropriate and relevant by the Study Management Committee. Interim and final results will be presented at various scientific congresses, meeting and in appropriate peer-reviewed scientific journals. Under no circumstances will personal identifier be revealed to any party not legally entitled to such information.
Publications
Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
PubMed 32123347Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.
PubMed 32083985Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.
PubMed 32052466Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
PubMed 32320003Thorlund K, Dron L, Park J, Hsu G, Forrest JI, Mills EJ. A real-time dashboard of clinical trials for COVID-19. Lancet Digit Health. 2020 Jun;2(6):e286-e287. doi: 10.1016/S2589-7500(20)30086-8. Epub 2020 Apr 24. No abstract available.
PubMed 32363333Yuen KS, Ye ZW, Fung SY, Chan CP, Jin DY. SARS-CoV-2 and COVID-19: The most important research questions. Cell Biosci. 2020 Mar 16;10:40. doi: 10.1186/s13578-020-00404-4. eCollection 2020.
PubMed 32190290
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Placebo-controlled, Double-blinded, Phase III Clinical Trial of the Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19
- ClinicalTrials.gov ID
- NCT04516811
- Acronym / sponsor ID
- PROTECT-Patient trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No benefit seen in 2 published inpatient RCTs (but had limitations). Press release from inpatient Recovery trial with large number of endpoints showed no benefit. CCP collected from survivors of original strain infection had no neutralisation
- Enrolment
- 102 participants (actual)
- Lead sponsor
- South African National Blood ServiceUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 18 Aug 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.
A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19
Detailed description
Full Title: A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19.
Short Title: PROTECT-Patient study
Aim: Assess the safety and efficacy of COVID-19 convalescent plasma (CCP) as a therapeutic treatment for hospitalised patients with moderate to severe COVID-19
Study Design: Randomised, double-blinded, placebo-controlled, phase III clinical trial
Intervention: Randomised 1:1 to either CCP plus standard of care (SOC) or to SOC plus placebo (200 mL normal saline)
Active Agent: A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.
Placebo: A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines
Sample Size: 600
Study Population: Consenting adult inpatients with moderate to severe COVID-19, not requiring invasive ventilation, who are admitted to a participating public or private sector hospital and who are not enrolled in another COVID-19 treatment trial.
Settings: Participating public and private sector hospitals in South Africa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participant identification numbers (PIN), assigned at the screening/enrolment visit, will be used throughout the study. After signing the informed consent document, eligible participants will be randomised to one of the treatment arms, stratified by study site, age group (<=65; >65 years old) and body mass index (BMI) (<30; >=30 kg/m2). An electronic randomisation application will generate the treatment allocation. The trial Program Manager (PM), who will have no direct contact with trial participants or involvement in eligibility assessment or outcome assignment, will maintain the randomisation code.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: COVID-19 convalescent plasma (CCP) plus standard of care (SOC)A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines. |
| Arm 2 | Placebo comparator | Biological: Standard of care (SOC) plus placeboA single unit of 200 mL normal saline with SOC as determined by local practice and guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Laboratory confirmed SARS-CoV-2 by positive RT-PCR on any respiratory sample;
- Age ≥ 18 years;
- Require hospital admission for COVID-19 pneumonia as defined by the presence of pulmonary infiltrates on chest x-ray;
- Moderate to severe Covid-19 disease, defined as: SpO2 ≤ 93% on room air; plus requiring non-invasive oxygen therapy (WHO R\&D BOSCI 4 or 5
- Signed informed consent;
Key exclusion criteria (4 listed)
- Current participation in another therapeutic clinical trial for COVID-19;
- Invasive mechanical ventilation;
- Expected survival < 24 hours based on clinical assessment (however, the study does not exclude critically ill patients who are not, due to resource limitations, candidates for critical care admission and/or mechanical ventilation);
- Known hypersensitivity to immunoglobulin or any components of the formulation;
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 convalescent plasma (CCP) plus standard of care (SOC)A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines. | Biological | Arm 1 |
| Standard of care (SOC) plus placeboA single unit of 200 mL normal saline with SOC as determined by local practice and guidelines | Biological | Arm 2 |
Primary outcome
Clinical Improvement
Time frame: Day 28
Proportion of participants with successful treatment outcome, defined as clinical improvement (≥ 2 points on WHO R\&D BOSCI 1) by Day 28 post-randomisation.
15 secondary outcomes
Adverse Events of special interest
Time frame: Day 28
Serious Adverse Events
Time frame: Day 28
Survival
Time frame: Day 28
Invasive mechanical ventilation
Time frame: Day 28
Disease severity
Time frame: Day 28
Time to outcomes of interest
Time frame: Day28
Length of stay meausures
Time frame: Day28
SARS-CoV PCR
Time frame: Day28
Inflammatory markers
Time frame: Day28
Radiography
Time frame: Day28
Fever & Hypoxia
Time frame: Day28
patients with HIV infection and other comorbidities
Time frame: Day 28
Timing of IP & Efficacy Outcome
Time frame: Day 28
Neutralising Ab
Time frame: Day28
SARS CoV Antibody titre
Time frame: Day28
Results and safety
The study was stopped early (reason given: No benefit seen in 2 published inpatient RCTs (but had limitations). Press release from inpatient Recovery trial with large number of endpoints showed no benefit. CCP collected from survivors of original strain infection had no neutralisation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 32123347Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32083985Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.
- Background: PubMed 32052466Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.
- Background: PubMed 32320003Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
- Background: PubMed 32363333Thorlund K, Dron L, Park J, Hsu G, Forrest JI, Mills EJ. A real-time dashboard of clinical trials for COVID-19. Lancet Digit Health. 2020 Jun;2(6):e286-e287. doi: 10.1016/S2589-7500(20)30086-8. Epub 2020 Apr 24. No abstract available.
- Results publication: PubMed 32190290Yuen KS, Ye ZW, Fung SY, Chan CP, Jin DY. SARS-CoV-2 and COVID-19: The most important research questions. Cell Biosci. 2020 Mar 16;10:40. doi: 10.1186/s13578-020-00404-4. eCollection 2020.
- Individual participant dataSharing planned: Yes. Where available and applicable, the results of this study will be reported to the appropriate scientific and management divisions of participating institutions. In addition, interim results may be communicated to lay press if doing so is deemed appropriate and relevant by the Study Management Committee. Interim and final results will be presented at various scientific congresses, meeting and in appropriate peer-reviewed scientific journals. Under no circumstances will personal identifier be revealed to any party not legally entitled to such information.
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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.
Sean Wasserman, A/Professor study chair
CIDRI-Africa, University of Cape Town
Karin vandenBerg, Dr principal investigator
South African National Blood Service
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of COVID-19 and SARS-CoV-2 Infection, run by South African National Blood Service at 2 sites in South Africa.
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 4 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: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. 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 phase mean?
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 stopped early (reason given: No benefit seen in 2 published inpatient RCTs (but had limitations). Press release from inpatient Recovery trial with large number of endpoints showed no benefit. CCP collected from survivors of original strain infection had no neutralisation). Results are not available in the source record.
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?
Clinical Improvement (time frame: Day 28). 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 NCT04516811, which also lists 7 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 8 May 2026.