Coronavirus Disease 2019 (COVID-19)Phase 2/3NCT04395170

Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

A Phase 2/3 study testing COVID-19 convalescent plasma, Anti-COVID-19 human immunoglobulin and Standard (specific) therapy for COVID-19 in people with Coronavirus Disease 2019 (COVID-19), run by Lifefactors Zona Franca, SAS at 1 site in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronavirus Disease 2019 (COVID-19)
What is being tested?: COVID-19 convalescent plasma, Anti-COVID-19 human immunoglobulin and Standard (specific) therapy for COVID-19
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteColombia
Study dates: Sep 2020to Jun 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

Obtaining the informed written consent before carrying out the study procedures, by the patients.
Adult patients ≥18 years at the time of recruitment for the study.
Patients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction on nasal/oropharyngeal swabs or any other relevant specimen <72 hours before randomization.
Patients requiring hospitalization for COVID-19 without mechanical ventilation (invasive or non-invasive, including an oxygen mask with reserve bag) and at least one of the following:
Radiographic evidence of pulmonary infiltrates by images (chest radiography, computed tomography, etc.),
Clinical evaluation (evidence of rales/crackles on examination) and oxygen saturation ≤ 94% in ambient air requiring supplemental oxygen.
Patient with no more than 72 hours (3 days) of hospitalization prior to the administration of PC treatment (except the days after initial hospital admission for other reasons and prior to COVID-19 infection).
Patients who do not have more than 10 days between the onset of symptoms (fever or cough) and the day of administration of treatment or the demonstration of the absence of anti-SARS-CoV-2 antibodies (patients with more than 10 days of symptoms they can only be included if a negative antibody result has been confirmed).

Who cannot join

Patient in a state of pregnancy.
Require mechanical ventilation (invasive or non-invasive, including oxygen mask with reserve bag) on examination.
Participation in any other clinical trial of an experimental treatment for COVID-19.
At the discretion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, regardless of the provision of treatments.
Any incompatibility or allergy to the administration of plasma of human origin.
Severe chronic kidney disease in stage 4 or requiring dialysis (that is, glomerular filtration rate <30).
Any condition that in the investigator's opinion limits participation in the study.

Trial locations and contacts

1 site in 1 country.

Santiago Jaramillo contact

+573128092776

sjaramillo@lifefactors.co

Colombia1 site

LifeFactors Zona Franca SAS
Medellín, Antioquia
Santiago Jaramillo, +57 3128092776, sjaramillo@lifefactors.co

Other trials in Colombia

About this study

Official title: A Randomized, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Use of Convalescent Plasma (PC) and Human Intravenous Anti COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

Read the detailed description

The study population will be patients (≥18 years) hospitalized by COVID-19 but still with an early form of the disease (in states 1-3 of the ordinal scale) who do not require mechanical ventilation (invasive or non-invasive) and who can give their consent informed.

All the participants will receive non-specific supportive treatment for COVID-19 such as oxygen, IV liquid or corticosteroids. Additionally, they will be randomized to one of the following arms:

Experimental arm 1: Plasma with inactivation/reduction of pathogens from convalescent patients with COVID-19 and who at the same time receive support therapy, in the 200 - 250 mL scheme, on days 1 and 3 of the intervention.

Experimental arm: Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenous at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:

Patient of 50 Kg or more, a dose of 50 mL will be applied on days 1 and 3 of treatment.

Patients of less than 50 Kg, the dose will be 1 mL / Kg, will be applied on days 1 and 3 of treatment.

This arm will be included once available. The supply of anti-COVID-19 human immunoglobulin produced by LifeFactors will be carried out once the national regulatory agency (Invima) grants authorization and/or the regulatory requirements for the production of medications are met.

Control arm: Standard (specific) therapy for COVID-19 according to the suggested pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are determined by the Colombian Health Regulatory Authorities.

Conditions: Coronavirus Disease 2019 (COVID-19)
Being tested: COVID-19 convalescent plasma, Anti-COVID-19 human immunoglobulin, Standard (specific) therapy for COVID-19
Keywords: coronavirus
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

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

COVID-19 convalescent plasmaBiological
Plasma from convalescent patients with COVID-19 and at the same time receiving supportive therapy, with inactivation / reduction of pathogens, in the scheme of two doses of 200 - 250 mL administered on days 1 and 3 of the intervention.
Anti-COVID-19 human immunoglobulinBiological
Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenously at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:
Patient of 50 Kg or more, a dose of 50 mL, administered on days 1 and 3 of treatment.
Patient under 50 Kg, the dose will be 1 mL / Kg, administered on days 1 and 3 of treatment.
The supply of anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S included once it has been authorized by INVIMA and/or the regulatory requirements in force for the production of drugs are met.
Standard (specific) therapy for COVID-19Drug
Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities.
To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.

Study groups in NCT04395170
Study group	Role	What they receive
Convalescent plasma	Experimental	Plasma from patients recovering from COVID-19. Receives: Biological: COVID-19 convalescent plasma
Anti-COVID-19 human immunoglobulin	Experimental	Anti-COVID-19 human immunoglobulin to be administered intravenously. Receives: Biological: Anti-COVID-19 human immunoglobulin
Standard (specific) therapy	Active comparator	Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities. To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin. Receives: Drug: Standard (specific) therapy for COVID-19

What is being measured

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

Admission to ICU and/or mechanical ventilation
Admission to the intensive care unit with the requirement of mechanical ventilation (invasive or non-invasive) due to Acute Respiratory Distress Syndrome by COVID-19.
Measured: One year

Secondary outcomes (4)

Length of hospital stay
Time in the hospital from admission to discharge or death.
Measured: One year
Neutralizing antibody (IgG) titers against COVID-19
Neutralizing antibody (IgG) titers against COVID-19
Measured: One year
Safety - Adverse events
Non-serious adverse events (NSAEs) and serious adverse events (SAEs)
Measured: One year
Death
Overall mortality
Measured: One year

Timeline

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

Sep 2020Jun 2021

First posted20 May 2020
Study startSep 2020 (estimated)
Primary completionDec 2020 (estimated)
Study completionJun 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Coronavirus Disease 2019 (COVID-19)Studies 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
Masking: None (open label)
Enrolment: 75 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04395170
Sponsor's protocol ID: LFCOLCOVID-19-001
Status last verified: Jul 2020
First submitted: 15 May 2020
Last updated: 10 Jul 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No.

Publications

Cancer Institute N. Common Terminology Criteria for Adverse Events (CTCAE) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [Internet]. 2017. Available from: https://www.meddra.org/
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
Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
PubMed 15616839
Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.
PubMed 15214887
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
Francis F, Hall M, Surg, Gaines A. Early use of convalescent serum in influenza. Mil Surg. 1920;47:177-9.
rice H, Genereux M, Sinclair C. Hyperimmune Immunoglobulin G. In: Production of Plasma Proteins for Therapeutic Use [Internet]. Hoboken, NJ, USA: John Wiley & Sons, Inc.; 2012.
Vargas M, Segura A, Wu YW, Herrera M, Chou ML, Villalta M, Leon G, Burnouf T. Human plasma-derived immunoglobulin G fractionated by an aqueous two-phase system, caprylic acid precipitation, and membrane chromatography has a high purity level and is free of detectable in vitro thrombogenic activity. Vox Sang. 2015 Feb;108(2):169-77. doi: 10.1111/vox.12209. Epub 2014 Dec 3.
PubMed 25469648
Redden WR. Treatment of Influenza-Pneumonia by Use of Convalescent Human Serum. Bost Med Surg J. 1919 Dec 11;181(24):688-91.
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
van Griensven J, Edwards T, Baize S; Ebola-Tx Consortium. Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies. N Engl J Med. 2016 Dec 8;375(23):2307-2309. doi: 10.1056/NEJMc1609116. Epub 2016 Nov 14. No abstract available.
PubMed 27959686
Zingher A, Mortimer P. Convalescent whole blood, plasma and serum in the prophylaxis of measles: JAMA, 12 April, 1926; 1180-1187. Rev Med Virol. 2005 Nov-Dec;15(6):407-18; discussion 418-21. doi: 10.1002/rmv.480. No abstract available.
PubMed 16211552
Use of Convalescent Whole Blood or Plasma Collected from Patients Recovered from Ebola Virus Disease for Transfusion, as an Empirical Treatment during Outbreaks Interim Guidance for National Health Authorities and Blood Transfusion Services Use of Convale. 2014.
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency | FDA [Internet]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

Want to know more?

Santiago Jaramillo

+573128092776

sjaramillo@lifefactors.co

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

Questions to ask the study team

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

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Use of Convalescent Plasma (PC) and Human Intravenous Anti COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.
ClinicalTrials.gov ID: NCT04395170
Acronym / sponsor ID: LFCOLCOVID-19-001
Conditions: Coronavirus Disease 2019 (COVID-19)
Keywords: coronavirus
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 75 participants (estimated)
Lead sponsor: Lifefactors Zona Franca, SASIndustry (pharma, biotech, devices)
Study start: Sep 2020 (estimated)
Primary completion: Dec 2020 (estimated)
Study completion: Jun 2021 (estimated)
First posted: 20 May 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.

Detailed description

All the participants will receive non-specific supportive treatment for COVID-19 such as oxygen, IV liquid or corticosteroids. Additionally, they will be randomized to one of the following arms:

Experimental arm: Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenous at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:

Patient of 50 Kg or more, a dose of 50 mL will be applied on days 1 and 3 of treatment.

Patients of less than 50 Kg, the dose will be 1 mL / Kg, will be applied on days 1 and 3 of treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Convalescent plasma	Experimental	Biological: COVID-19 convalescent plasmaPlasma from patients recovering from COVID-19.
Anti-COVID-19 human immunoglobulin	Experimental	Biological: Anti-COVID-19 human immunoglobulinAnti-COVID-19 human immunoglobulin to be administered intravenously.
Standard (specific) therapy	Active comparator	Drug: Standard (specific) therapy for COVID-19Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities. To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.

Who may qualify

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

Key inclusion criteria (8 listed)

Obtaining the informed written consent before carrying out the study procedures, by the patients.
Adult patients ≥18 years at the time of recruitment for the study.
Patients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction on nasal/oropharyngeal swabs or any other relevant specimen <72 hours before randomization.
Patients requiring hospitalization for COVID-19 without mechanical ventilation (invasive or non-invasive, including an oxygen mask with reserve bag) and at least one of the following:
Patient with no more than 72 hours (3 days) of hospitalization prior to the administration of PC treatment (except the days after initial hospital admission for other reasons and prior to COVID-19 infection).

Key exclusion criteria (7 listed)

Patient in a state of pregnancy.
Require mechanical ventilation (invasive or non-invasive, including oxygen mask with reserve bag) on examination.
Participation in any other clinical trial of an experimental treatment for COVID-19.
At the discretion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, regardless of the provision of treatments.
Any incompatibility or allergy to the administration of plasma of human origin.

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 plasmaPlasma from convalescent patients with COVID-19 and at the same time receiving supportive therapy, with inactivation / reduction of pathogens, in the scheme of two doses of 200 - 250 mL administered on days 1 and 3 of the intervention.	Biological	Convalescent plasma
Anti-COVID-19 human immunoglobulinAnti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenously at a dose of immunoglobulin 10% IgG solution (10% mL vial) for: Patient of 50 Kg or more, a dose of 50 mL, administered on days 1 and 3 of treatment. Patient under 50 Kg, the dose will be 1 mL / Kg, administered on days 1 and 3 of treatment. The supply of anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S included once it has been authorized by INVIMA and/or the regulatory requirements in force for the production of drugs are met.	Biological	Anti-COVID-19 human immunoglobulin
Standard (specific) therapy for COVID-19Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities. To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.	Drug	Standard (specific) therapy

Primary outcome

Admission to ICU and/or mechanical ventilation
Time frame: One year
Admission to the intensive care unit with the requirement of mechanical ventilation (invasive or non-invasive) due to Acute Respiratory Distress Syndrome by COVID-19.

4 secondary outcomes

Length of hospital stay
Time frame: One year
Neutralizing antibody (IgG) titers against COVID-19
Time frame: One year
Safety - Adverse events
Time frame: One year
Death
Time frame: One year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
BackgroundCancer Institute N. Common Terminology Criteria for Adverse Events (CTCAE) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [Internet]. 2017. Available from: https://www.meddra.org/
Results publication: 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.
Results publication: PubMed 15616839Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
Results publication: PubMed 15214887Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.
Results publication: 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.
Results publicationFrancis F, Hall M, Surg, Gaines A. Early use of convalescent serum in influenza. Mil Surg. 1920;47:177-9.
Results publicationrice H, Genereux M, Sinclair C. Hyperimmune Immunoglobulin G. In: Production of Plasma Proteins for Therapeutic Use [Internet]. Hoboken, NJ, USA: John Wiley & Sons, Inc.; 2012.
Results publication: PubMed 25469648Vargas M, Segura A, Wu YW, Herrera M, Chou ML, Villalta M, Leon G, Burnouf T. Human plasma-derived immunoglobulin G fractionated by an aqueous two-phase system, caprylic acid precipitation, and membrane chromatography has a high purity level and is free of detectable in vitro thrombogenic activity. Vox Sang. 2015 Feb;108(2):169-77. doi: 10.1111/vox.12209. Epub 2014 Dec 3.
Results publicationRedden WR. Treatment of Influenza-Pneumonia by Use of Convalescent Human Serum. Bost Med Surg J. 1919 Dec 11;181(24):688-91.
Results publication: PubMed 12777656Wong 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.
Results publication: PubMed 27959686van Griensven J, Edwards T, Baize S; Ebola-Tx Consortium. Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies. N Engl J Med. 2016 Dec 8;375(23):2307-2309. doi: 10.1056/NEJMc1609116. Epub 2016 Nov 14. No abstract available.
Results publication: PubMed 16211552Zingher A, Mortimer P. Convalescent whole blood, plasma and serum in the prophylaxis of measles: JAMA, 12 April, 1926; 1180-1187. Rev Med Virol. 2005 Nov-Dec;15(6):407-18; discussion 418-21. doi: 10.1002/rmv.480. No abstract available.
Individual participant dataSharing planned: No. 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.

Santiago Jaramillo contact

+573128092776

sjaramillo@lifefactors.co

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

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Jul 2020. 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 Colombia. 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 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?

Results are not available in the source record.

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

Contact Santiago Jaramillo (+573128092776, sjaramillo@lifefactors.co), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Admission to ICU and/or mechanical ventilation (time frame: One year). 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 NCT04395170, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.