Covid19Phase 2/3BeeCovid2NCT04800224

Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients (BeeCovid2)

A Phase 2/3 study testing Standardized Brazilian Green Propolis Extract in people with Covid19 and Inflammation, run by D'Or Institute for Research and Education at 1 site in Brazil.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, Inflammation
What is being tested?: Standardized Brazilian Green Propolis Extract
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteBrazil
Study dates: 12 Apr 2021to 30 Jul 2021
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

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

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Older than 18 years;
Diagnosis of coronavirus infection confirmed by polymerase chain reaction - reverse transcriptase testing;
Symptoms started within 14 days of the randomization date

Who cannot join

Pregnant or lactating women;
Known hypersensitivity to propolis;
Propolis use less than 30 days from the randomization date;
Active cancer;
Human immunodeficiency virus carriers;
Patients undergoing transplantation of solid organs or bone marrow or who were using immunosuppressive medications;

Show all 10Show fewer

Bacterial infection at randomization, sepsis or septic shock related to bacterial infection at randomization;
Impossibility of using the medication orally or by nasoenteral tube;
Known hepatic failure or advanced heart failure (New York Heart Association [NYHA] class III or IV).
End Stage Renal Disease (ESRD).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital Sao Rafael
Salvador, Estado de Bahia, 41820340

Other trials in Brazil

About this study

Official title: The Use of the Standardized Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients: A Randomized, Double-blind, Placebo-controlled Trial

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promotes challenging immune and inflammatory phenomena. Though various therapeutic possibilities have been tested against coronavirus disease 2019 (COVID-19), the most adequate treatment has not yet been established. Among candidate adjunct treatment options, propolis, produced by honey bees from bioactive plant exudates, has shown potential against viral targets and has demonstrated immunoregulatory properties.

Read the detailed description

To evaluate the efficacy and safety of oral propolis as an adjunct treatment for SARS-CoV-2 infection, we designed a randomized, double-blind, placebo-controlled trial (Bee-Covid2) (The Use of Brazilian Green Propolis Extract (EPP-AF®) in Patients Affected by COVID-19).

Conditions: Covid19, Inflammation
Being tested: Standardized Brazilian Green Propolis Extract, Placebo
Keywords: Propolis, Covid19, Anti-Inflammatory Agents, Immunoregulation
Medical subject headings: COVID-19, Inflammation

What participants receive

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

Standardized Brazilian Green Propolis ExtractDrug
Also called Propolis
900mg/day of Standardized Brazilian Green Propolis Extract for 10 days.
PlaceboDrug
900mg/day of Placebo for 10 days.

Study groups in NCT04800224
Study group	Role	What they receive
Placebo	Placebo comparator	Patients in the Placebo group will receive an identical number of capsules containing 900 mg / day of placebo (3 capsules of 100 mg each, divided into 3 daily doses); for 10 days. Receives: Drug: Placebo
Propolis	Active comparator	Participants in the Propolis group will receive propolis EPP-AF at a dose of 900 mg / day (3 capsules of 100 mg each, divided into 3 daily doses); for 10 days. Receives: Drug: Standardized Brazilian Green Propolis Extract

What is being measured

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

Length of hospital stay
Hospitalization time after randomization (in days)
Measured: 1-28 days

Secondary outcomes (8)

Percentage of participants with adverse events during the use of propolis or placebo
We will evaluate the presence or absence of symptoms related to the use of propolis or placebo.
Measured: 1-28 days
Rate and severity of acute kidney injury during the study
Assess the degree of acute kidney injury according to KDIGO.
Measured: 1-28 days
Renal replacement therapy.
Assess need or not for renal replacement therapy
Measured: 1-28 days
Rate of need for vasopressor use.
Describe the time needed for vasopressors in days after randomization.
Measured: 1-28 days
Intensive care unit (ICU) readmission
Rate of readmission to the ICU after randomization
Measured: 1-28 days
Invasive oxygenation time
Assess the need for mechanical ventilation in days after randomization.
Measured: 1-28 days
Need for Intra-Aortic Balloon Pump
Assess the need for Intra-Aortic Balloon Pump in days after randomization.
Measured: 1-28 days
Need for Extracorporeal Oxygenation Membrane (ECMO)
Assess the need for Extracorporeal Oxygenation Membrane in days after randomization.
Measured: 1-28 days

Timeline

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

12 Apr 202130 Jul 2021

First posted16 Mar 2021
Study start12 Apr 2021
Primary completion30 Jul 2021
Study completion30 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomized, double-blind, placebo-controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04800224
Sponsor's protocol ID: 31099320.6.0000.0049
Acronym: BeeCovid2
Status last verified: May 2022
First submitted: 12 Mar 2021
Last updated: 13 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data presented in this study are available on request from the corresponding author.

Publications

Silveira MAD, Capcha JMC, Sanches TR, de Sousa Moreira R, Garnica MS, Shimizu MH, Berretta A, Teles F, Noronha IL, Andrade L. Green propolis extract attenuates acute kidney injury and lung injury in a rat model of sepsis. Sci Rep. 2021 Mar 15;11(1):5925. doi: 10.1038/s41598-021-85124-6.
PubMed 33723330
Silveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7.
PubMed 31023272
MAD Silveira, D De Jong, AA Berretta, et.al. Efficacy of propolis as an adjunct treatment for hospitalized COVID-19 patients: a randomized, controlled clinical trial. MedRxiv preprint doi: https://doi.org/10.1101/2021.01.08.20248932.
Berretta AA, Silveira MAD, Condor Capcha JM, De Jong D. Propolis and its potential against SARS-CoV-2 infection mechanisms and COVID-19 disease: Running title: Propolis against SARS-CoV-2 infection and COVID-19. Biomed Pharmacother. 2020 Nov;131:110622. doi: 10.1016/j.biopha.2020.110622. Epub 2020 Aug 17.
PubMed 32890967
Maruta H, He H. PAK1-blockers: Potential Therapeutics against COVID-19. Med Drug Discov. 2020 Jun;6:100039. doi: 10.1016/j.medidd.2020.100039. Epub 2020 Apr 19.
PubMed 32313880
Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
PubMed 32142651
Machado JL, Assuncao AK, da Silva MC, Dos Reis AS, Costa GC, Arruda Dde S, Rocha BA, Vaz MM, Paes AM, Guerra RN, Berretta AA, do Nascimento FR. Brazilian green propolis: anti-inflammatory property by an immunomodulatory activity. Evid Based Complement Alternat Med. 2012;2012:157652. doi: 10.1155/2012/157652. Epub 2012 Dec 19.
PubMed 23320022
Shimizu T, Hino A, Tsutsumi A, Park YK, Watanabe W, Kurokawa M. Anti-influenza virus activity of propolis in vitro and its efficacy against influenza infection in mice. Antivir Chem Chemother. 2008;19(1):7-13. doi: 10.1177/095632020801900102.
PubMed 18610553
Ito J, Chang FR, Wang HK, Park YK, Ikegaki M, Kilgore N, Lee KH. Anti-AIDS agents. 48.(1) Anti-HIV activity of moronic acid derivatives and the new melliferone-related triterpenoid isolated from Brazilian propolis. J Nat Prod. 2001 Oct;64(10):1278-81. doi: 10.1021/np010211x.
PubMed 11678650
Berretta AA, Nascimento AP, Bueno PC, Vaz MM, Marchetti JM. Propolis standardized extract (EPP-AF(R)), an innovative chemically and biologically reproducible pharmaceutical compound for treating wounds. Int J Biol Sci. 2012;8(4):512-21. doi: 10.7150/ijbs.3641. Epub 2012 Mar 21.
PubMed 22457606
Silveira MAD, Menezes MA, de Souza SP, Galvao EBDS, Berretta AA, Caldas J, Teixeira MB, Gomes MMD, Damiani LP, Bahiense BA, Cabral JB, De Oliveira CWLM, Mascarenhas TR, Pinheiro PCG, Alves MS, de Melo RMV, Leite FM, Nonaka CKV, Souza BSF, Baptista NU, Teles F, da Guarda SF, Mendes AVA, Passos RDH. Standardized Brazilian green propolis extract (EPP-AF(R)) in COVID-19 outcomes: a randomized double-blind placebo-controlled trial. Sci Rep. 2023 Oct 27;13(1):18405. doi: 10.1038/s41598-023-43764-w.
PubMed 37891178
Silveira MAD, de Souza SP, Dos Santos Galvao EB, Teixeira MB, Gomes MMD, Damiani LP, Bahiense BA, Cabral JB, De Oliveira CWLM, Mascarenhas TR, Pinheiro PCG, Alves MS, de Melo RMV, Berretta AA, Leite FM, Nonaka CKV, de Freitas Souza BS, Mendes AVA, da Guarda SF, da Hora Passos R. The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial. Trials. 2022 Apr 4;23(1):255. doi: 10.1186/s13063-022-06176-1.
PubMed 35379306

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?

See locations

RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2

All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of the Standardized Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients: A Randomized, Double-blind, Placebo-controlled Trial
ClinicalTrials.gov ID: NCT04800224
Acronym / sponsor ID: BeeCovid2 / 31099320.6.0000.0049
Conditions: Covid19, Inflammation
Keywords: Propolis, Covid19, Anti-Inflammatory Agents, Immunoregulation
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: D'Or Institute for Research and EducationUniversity, hospital or other
Collaborators: Apis Flora Industrial e Comercial Ltda
Study start: 12 Apr 2021 (actual)
Primary completion: 30 Jul 2021 (actual)
Study completion: 30 Jul 2021 (actual)
First posted: 16 Mar 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: A randomized, double-blind, placebo-controlled trial

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPatients in the Placebo group will receive an identical number of capsules containing 900 mg / day of placebo (3 capsules of 100 mg each, divided into 3 daily doses); for 10 days.
Propolis	Active comparator	Drug: Standardized Brazilian Green Propolis ExtractParticipants in the Propolis group will receive propolis EPP-AF at a dose of 900 mg / day (3 capsules of 100 mg each, divided into 3 daily doses); for 10 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Older than 18 years;
Diagnosis of coronavirus infection confirmed by polymerase chain reaction - reverse transcriptase testing;
Symptoms started within 14 days of the randomization date

Key exclusion criteria (10 listed)

Pregnant or lactating women;
Known hypersensitivity to propolis;
Propolis use less than 30 days from the randomization date;
Active cancer;
Human immunodeficiency virus carriers;

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
Standardized Brazilian Green Propolis ExtractAlso: Propolis900mg/day of Standardized Brazilian Green Propolis Extract for 10 days.	Drug	Propolis
Placebo900mg/day of Placebo for 10 days.	Drug	Placebo

Primary outcome

Length of hospital stay
Time frame: 1-28 days
Hospitalization time after randomization (in days)

8 secondary outcomes

Percentage of participants with adverse events during the use of propolis or placebo
Time frame: 1-28 days
Rate and severity of acute kidney injury during the study
Time frame: 1-28 days
Renal replacement therapy.
Time frame: 1-28 days
Rate of need for vasopressor use.
Time frame: 1-28 days
Intensive care unit (ICU) readmission
Time frame: 1-28 days
Invasive oxygenation time
Time frame: 1-28 days
Need for Intra-Aortic Balloon Pump
Time frame: 1-28 days
Need for Extracorporeal Oxygenation Membrane (ECMO)
Time frame: 1-28 days

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 13 May 2022.
Background: PubMed 33723330Silveira MAD, Capcha JMC, Sanches TR, de Sousa Moreira R, Garnica MS, Shimizu MH, Berretta A, Teles F, Noronha IL, Andrade L. Green propolis extract attenuates acute kidney injury and lung injury in a rat model of sepsis. Sci Rep. 2021 Mar 15;11(1):5925. doi: 10.1038/s41598-021-85124-6.
Background: PubMed 31023272Silveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7.
BackgroundMAD Silveira, D De Jong, AA Berretta, et.al. Efficacy of propolis as an adjunct treatment for hospitalized COVID-19 patients: a randomized, controlled clinical trial. MedRxiv preprint doi: https://doi.org/10.1101/2021.01.08.20248932.
Background: PubMed 32890967Berretta AA, Silveira MAD, Condor Capcha JM, De Jong D. Propolis and its potential against SARS-CoV-2 infection mechanisms and COVID-19 disease: Running title: Propolis against SARS-CoV-2 infection and COVID-19. Biomed Pharmacother. 2020 Nov;131:110622. doi: 10.1016/j.biopha.2020.110622. Epub 2020 Aug 17.
Background: PubMed 32313880Maruta H, He H. PAK1-blockers: Potential Therapeutics against COVID-19. Med Drug Discov. 2020 Jun;6:100039. doi: 10.1016/j.medidd.2020.100039. Epub 2020 Apr 19.
Background: PubMed 32142651Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
Background: PubMed 23320022Machado JL, Assuncao AK, da Silva MC, Dos Reis AS, Costa GC, Arruda Dde S, Rocha BA, Vaz MM, Paes AM, Guerra RN, Berretta AA, do Nascimento FR. Brazilian green propolis: anti-inflammatory property by an immunomodulatory activity. Evid Based Complement Alternat Med. 2012;2012:157652. doi: 10.1155/2012/157652. Epub 2012 Dec 19.
Background: PubMed 18610553Shimizu T, Hino A, Tsutsumi A, Park YK, Watanabe W, Kurokawa M. Anti-influenza virus activity of propolis in vitro and its efficacy against influenza infection in mice. Antivir Chem Chemother. 2008;19(1):7-13. doi: 10.1177/095632020801900102.
Background: PubMed 11678650Ito J, Chang FR, Wang HK, Park YK, Ikegaki M, Kilgore N, Lee KH. Anti-AIDS agents. 48.(1) Anti-HIV activity of moronic acid derivatives and the new melliferone-related triterpenoid isolated from Brazilian propolis. J Nat Prod. 2001 Oct;64(10):1278-81. doi: 10.1021/np010211x.
Background: PubMed 22457606Berretta AA, Nascimento AP, Bueno PC, Vaz MM, Marchetti JM. Propolis standardized extract (EPP-AF(R)), an innovative chemically and biologically reproducible pharmaceutical compound for treating wounds. Int J Biol Sci. 2012;8(4):512-21. doi: 10.7150/ijbs.3641. Epub 2012 Mar 21.
Derived from this study: PubMed 37891178Silveira MAD, Menezes MA, de Souza SP, Galvao EBDS, Berretta AA, Caldas J, Teixeira MB, Gomes MMD, Damiani LP, Bahiense BA, Cabral JB, De Oliveira CWLM, Mascarenhas TR, Pinheiro PCG, Alves MS, de Melo RMV, Leite FM, Nonaka CKV, Souza BSF, Baptista NU, Teles F, da Guarda SF, Mendes AVA, Passos RDH. Standardized Brazilian green propolis extract (EPP-AF(R)) in COVID-19 outcomes: a randomized double-blind placebo-controlled trial. Sci Rep. 2023 Oct 27;13(1):18405. doi: 10.1038/s41598-023-43764-w.
Derived from this study: PubMed 35379306Silveira MAD, de Souza SP, Dos Santos Galvao EB, Teixeira MB, Gomes MMD, Damiani LP, Bahiense BA, Cabral JB, De Oliveira CWLM, Mascarenhas TR, Pinheiro PCG, Alves MS, de Melo RMV, Berretta AA, Leite FM, Nonaka CKV, de Freitas Souza BS, Mendes AVA, da Guarda SF, da Hora Passos R. The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial. Trials. 2022 Apr 4;23(1):255. doi: 10.1186/s13063-022-06176-1.
Individual participant dataSharing planned: No. The data presented in this study are available on request from the corresponding author.

Related trials for Covid19

RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2

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.

Marcelo Silveira, MD, PhD principal investigator

D'Or Institute for Research and Education (IDOR)

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Standardized Brazilian Green Propolis Extract in people with Covid19 and Inflammation, run by D'Or Institute for Research and Education at 1 site in Brazil.

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 3 inclusion and 10 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 May 2022. 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 Brazil. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study 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?

Length of hospital stay (time frame: 1-28 days). 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 NCT04800224, which also lists 12 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 May 2022; AzTrials last refreshed its copy on 5 Nov 2026.