SARS-Associated CoronavirusPhase 2NCT04468009

Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma

A Phase 2 study testing Convalescent plasma in people with SARS-Associated Coronavirus and Covid19, run by Hospital de Infecciosas Francisco Javier Muniz at 1 site in Argentina.

Completed

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

Official record

Search all trials

Trial summary

This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit. Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: SARS-Associated Coronavirus, Covid19, SARS-CoV Infection
What is being tested?: Convalescent plasma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteArgentina
Study dates: 25 Jun 2020to 19 Jun 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age: 18 years or more.
Patient with Covid-19 confirmed with nuclear acid testing
Critically ill patients with Covid-19 on mechanical ventilation. Potencially critically ill patients (with acute respiratory distress syndrome, septic shock and/or multiple organ failure) with Covid-19.
Diagnosed with acute respiratory distress syndrome.
Informed consent.

Who cannot join

No consent.
Symptoms for a period longer than 20 days.
Not detectable by acid nuclear testing within 48 hours prior to elegibility.
Descompensated congestive heart failure, in which receiving 500ml of intrasvascular volume signifies a life risk.
History of severe adverse events or anaphylaxis to plasma components

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Hospital Francisco Javier Muñiz
Ciudad Autonoma de Buenos Aire, 1663

Other trials in Argentina

About this study

This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.

Read the detailed description

This study aims to use convalescent plasma as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit. Donors must have anti-SARS CoV2 antibodies. Recipients must be critically ill Covid-19 patients on mechanical ventilation.

Conditions: SARS-Associated Coronavirus, Covid19, SARS-CoV Infection
Being tested: Convalescent plasma
Keywords: Convalescent plasma, Covid-19 treatment, Transfusion medicine
Medical subject headings: Severe Acute Respiratory Syndrome, COVID-19

What participants receive

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

Convalescent plasmaBiological
Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies

Study groups in NCT04468009
Study group	Role	What they receive
Standard of care	No intervention	Standard of care for Covid-19
PCC-19	Experimental	Treatment with convalescent plasma Receives: Biological: Convalescent plasma

What is being measured

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

Mortality at ICU at 30 days
Mortality at 30 days of Intensive Care Unit (ICU) admission
Measured: Mortality at 30 days
Mortality at ICU at 90 days
Mortality at 90 days of ICU admission
Measured: Mortality at 90 days

Secondary outcomes (5)

SOFA score of study days 1, 3, 5, 7, 14 and 28
Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28
Measured: Study days 1, 3, 5, 7, 14 and 28
Need for supportive therapy after enrollment
Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment
Measured: Duration of supportive therapy through study completion, an average of 3 months
Lenght of stay in ICU
Duration (number of days) of stay in ICU between ICU admission and ICU final discharge
Measured: Duration of stay in ICU through study completion, an average of 3 months
Lenght of mechanical ventilation
Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation
Measured: Duration of mechanical ventilation through study completion, an average of 3 months
Lenght of hospitalization
Duration (number of days) of hospitalization between hospital admission and final hospital discharge
Measured: Duration of hospitalization through study completion, an average of 3 months

Timeline

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

25 Jun 202019 Jun 2021

First posted13 Jul 2020
Study start25 Jun 2020
Primary completion19 Jan 2021
Study completion19 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for SARS-Associated CoronavirusStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04468009
Sponsor's protocol ID: 1725
Status last verified: Aug 2021
First submitted: 9 Jul 2020
Last updated: 25 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Enria DA, Briggiler AM, Fernandez NJ, Levis SC, Maiztegui JI. Importance of dose of neutralising antibodies in treatment of Argentine haemorrhagic fever with immune plasma. Lancet. 1984 Aug 4;2(8397):255-6. doi: 10.1016/s0140-6736(84)90299-x.
PubMed 6146809
Rojas M, Rodriguez Y, Monsalve DM, Acosta-Ampudia Y, Camacho B, Gallo JE, Rojas-Villarraga A, Ramirez-Santana C, Diaz-Coronado JC, Manrique R, Mantilla RD, Shoenfeld Y, Anaya JM. Convalescent plasma in Covid-19: Possible mechanisms of action. Autoimmun Rev. 2020 Jul;19(7):102554. doi: 10.1016/j.autrev.2020.102554. Epub 2020 May 5.
PubMed 32380316
Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
PubMed 32253318
Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
PubMed 32219428
Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Jul;158(1):e9-e13. doi: 10.1016/j.chest.2020.03.039. Epub 2020 Mar 31.
PubMed 32243945
Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.
PubMed 32281317
Ye M, Fu D, Ren Y, Wang F, Wang D, Zhang F, Xia X, Lv T. Treatment with convalescent plasma for COVID-19 patients in Wuhan, China. J Med Virol. 2020 Oct;92(10):1890-1901. doi: 10.1002/jmv.25882. Epub 2020 Jun 29.
PubMed 32293713
Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.
PubMed 32356910
Joyner M, Wright RS, Fairweather D, Senefeld J, Bruno K, Klassen S, Carter R, Klompas A, Wiggins C, Shepherd JR, Rea R, Whelan E, Clayburn A, Spiegel M, Johnson P, Lesser E, Baker S, Larson K, Ripoll Sanz J, Andersen K, Hodge D, Kunze K, Buras M, Vogt M, Herasevich V, Dennis J, Regimbal R, Bauer P, Blair J, van Buskirk C, Winters J, Stubbs J, Paneth N, Casadevall A. Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients. medRxiv [Preprint]. 2020 May 14:2020.05.12.20099879. doi: 10.1101/2020.05.12.20099879.
PubMed 32511566
Valk SJ, Piechotta V, Chai KL, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review. Cochrane Database Syst Rev. 2020 May 14;5(5):CD013600. doi: 10.1002/14651858.CD013600.
PubMed 32406927
Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
PubMed 25030060
Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.
PubMed 32198501
To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
PubMed 32213337
Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: passive immunotherapy for influenza and other serious infections. Crit Care Med. 2010 Apr;38(4 Suppl):e66-73. doi: 10.1097/CCM.0b013e3181d44c1e.
PubMed 20154602
Wong VW, Dai D, Wu AK, Sung JJ. Treatment of severe acute respiratory syndrome with convalescent plasma. Hong Kong Med J. 2003 Jun;9(3):199-201.
PubMed 12777656

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma
ClinicalTrials.gov ID: NCT04468009
Acronym / sponsor ID: 1725
Conditions: SARS-Associated Coronavirus, Covid19, SARS-CoV Infection
Keywords: Convalescent plasma, Covid-19 treatment, Transfusion medicine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Hospital de Infecciosas Francisco Javier MunizOther government
Study start: 25 Jun 2020 (actual)
Primary completion: 19 Jan 2021 (actual)
Study completion: 19 Jun 2021 (actual)
First posted: 13 Jul 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.

This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of care	No intervention	–Standard of care for Covid-19
PCC-19	Experimental	Biological: Convalescent plasmaTreatment with convalescent plasma

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age: 18 years or more.
Patient with Covid-19 confirmed with nuclear acid testing
Critically ill patients with Covid-19 on mechanical ventilation. Potencially critically ill patients (with acute respiratory distress syndrome, septic shock and/or multiple organ failure) with Covid-19.
Diagnosed with acute respiratory distress syndrome.
Informed consent.

Key exclusion criteria (5 listed)

No consent.
Symptoms for a period longer than 20 days.
Not detectable by acid nuclear testing within 48 hours prior to elegibility.
Descompensated congestive heart failure, in which receiving 500ml of intrasvascular volume signifies a life risk.
History of severe adverse events or anaphylaxis to plasma components

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
Convalescent plasmaConvalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies	Biological	PCC-19

Primary outcome

Mortality at ICU at 30 days
Time frame: Mortality at 30 days
Mortality at 30 days of Intensive Care Unit (ICU) admission
Mortality at ICU at 90 days
Time frame: Mortality at 90 days
Mortality at 90 days of ICU admission

5 secondary outcomes

SOFA score of study days 1, 3, 5, 7, 14 and 28
Time frame: Study days 1, 3, 5, 7, 14 and 28
Need for supportive therapy after enrollment
Time frame: Duration of supportive therapy through study completion, an average of 3 months
Lenght of stay in ICU
Time frame: Duration of stay in ICU through study completion, an average of 3 months
Lenght of mechanical ventilation
Time frame: Duration of mechanical ventilation through study completion, an average of 3 months
Lenght of hospitalization
Time frame: Duration of hospitalization through study completion, an average of 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
Background: PubMed 6146809Enria DA, Briggiler AM, Fernandez NJ, Levis SC, Maiztegui JI. Importance of dose of neutralising antibodies in treatment of Argentine haemorrhagic fever with immune plasma. Lancet. 1984 Aug 4;2(8397):255-6. doi: 10.1016/s0140-6736(84)90299-x.
Background: PubMed 32380316Rojas M, Rodriguez Y, Monsalve DM, Acosta-Ampudia Y, Camacho B, Gallo JE, Rojas-Villarraga A, Ramirez-Santana C, Diaz-Coronado JC, Manrique R, Mantilla RD, Shoenfeld Y, Anaya JM. Convalescent plasma in Covid-19: Possible mechanisms of action. Autoimmun Rev. 2020 Jul;19(7):102554. doi: 10.1016/j.autrev.2020.102554. Epub 2020 May 5.
Background: PubMed 32253318Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
Background: PubMed 32219428Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
Background: PubMed 32243945Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Jul;158(1):e9-e13. doi: 10.1016/j.chest.2020.03.039. Epub 2020 Mar 31.
Background: PubMed 32281317Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.
Background: PubMed 32293713Ye M, Fu D, Ren Y, Wang F, Wang D, Zhang F, Xia X, Lv T. Treatment with convalescent plasma for COVID-19 patients in Wuhan, China. J Med Virol. 2020 Oct;92(10):1890-1901. doi: 10.1002/jmv.25882. Epub 2020 Jun 29.
Background: PubMed 32356910Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.
Background: PubMed 32511566Joyner M, Wright RS, Fairweather D, Senefeld J, Bruno K, Klassen S, Carter R, Klompas A, Wiggins C, Shepherd JR, Rea R, Whelan E, Clayburn A, Spiegel M, Johnson P, Lesser E, Baker S, Larson K, Ripoll Sanz J, Andersen K, Hodge D, Kunze K, Buras M, Vogt M, Herasevich V, Dennis J, Regimbal R, Bauer P, Blair J, van Buskirk C, Winters J, Stubbs J, Paneth N, Casadevall A. Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients. medRxiv [Preprint]. 2020 May 14:2020.05.12.20099879. doi: 10.1101/2020.05.12.20099879.
Background: PubMed 32406927Valk SJ, Piechotta V, Chai KL, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review. Cochrane Database Syst Rev. 2020 May 14;5(5):CD013600. doi: 10.1002/14651858.CD013600.
Background: PubMed 25030060Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
Background: PubMed 32198501Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.
Individual participant dataSharing planned: No

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.

Carlos A Gonzalez, MD principal investigator

Hospital de Infecciosas Francisco Javier Muniz

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Convalescent plasma in people with SARS-Associated Coronavirus and Covid19, run by Hospital de Infecciosas Francisco Javier Muniz at 1 site in Argentina.

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 5 inclusion and 5 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 25 Aug 2021. 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 Argentina. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality at ICU at 30 days (time frame: Mortality at 30 days). The study lists 2 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 NCT04468009, which also lists 25 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 25 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.