SARS VirusPLASM-ARNCT04383535
Convalescent Plasma and Placebo for the Treatment of COVID-19 Severe Pneumonia
A study testing Convalescent SARS COVID-19 plasma in people with SARS Virus and SARS-CoV-2, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
A multicenter randomized, double-blind, placebo-controlled clinical trial of Convalescent SARS COVID-19 plasma versus Placebo to evaluate the effect between arms on an ordinal score of six mutually exclusive categories of clinical status at day 30 after study initiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS Virus, SARS-CoV-2, COVID-19
- What is being tested?
- Convalescent SARS COVID-19 plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 1 siteArgentina
- Study dates
- 15 May 2020to 27 Sep 2020
- Phase
- Interventional
- 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
- Confirmed diagnosis of Covid-19 through qualitative polymerase-reverse transcriptase (qRT-PCR -GeneDX Co, Ltd o similar).
- Imagining-diagnosed pneumonia (Rx or CT scan).
- MSOFA score (Modified SOFA) of 2 or more (modified organic failure assessment)
- Informed consent.
Who cannot join
- Pregnant women
- Women at reproductive age not willing to avoid unprotected sexual intercourse up to Day 30 after study initiation.
- Women in the breastfeeding period
- Patients receiving experimental treatments under development within 30 days prior to study initiation.
- Patients with a previous history of allergic reactions to blood or blood-components transfusion.
- Diagnosis or clinical suspicion of an alternative microbiological cause for pneumonia besides COVID-19
- Use of systemic corticosteroids within 15 days prior to entering the study.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1181
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial of Convalescent Plasma for the Treatment of COVID-19 Pneumonia With Severity Criteria
A multicenter randomized, double-blind, placebo-controlled clinical trial of Convalescent SARS COVID-19 plasma versus Placebo to evaluate the effect between arms on an ordinal score of six mutually exclusive categories of clinical status at day 30 after study initiation.
Read the detailed description
Introduction
The use of convalescent plasma in the treatment of infectious diseases has been empirically performed for more than a century. It is based upon the assumption that providing exogenous neutralizing antibodies may provide protection while affected patients mount their own immune response. This therapeutic approach appears of particular interest in the context of the current pandemic, in which there is no specific vaccine available nor adequately proven effective pharmacological treatments.
Study purpose, hypothesis and general design
Purpose of the study: evaluate the effectiveness and safety of convalescent plasma in the treatment of SARS-CoV-2 pneumonia (Covid-19) Hypothesis: Convalescent plasma significantly improves the clinical outcome in patients with Covid-19 pneumonia and severity criteria.
Multicenter randomized, double-blind, placebo.controlled clinical trial. Placebo will be a saline solution.
- Methodological sustain for including a control arm with placebo Quality evidence about the effectiveness of convalescent plasma in the treatment of Covid-19 pneumonia is not yet available. Although case series and anecdotal reports appear encouraging, the implementation of its use in routine clinical practice requires the validation through controlled clinical trials. In addition the collection, administration and control of plasma is technically demanding and needs a clear support before broadly recommending it. Different scientific institutions and international organisms had clearly suggested to prioritize the application of novel therapeutic techniques with yet unproven efficacy within the context of clinical studies over its empirical use.
On the other hand, for the present study, intervention strategy is proposed in "add-on" modality over the antiviral treatment that each participant may be already receiving, since they represent completely different therapeutic approaches. As such, participation in the present study will not condition the possibility of the participants to receive other treatments, either in intervention or control arms.
- Study objectives Primary objective Analyze the difference between arms on an ordinal score of six mutually exclusive categories at day 30 after study initiation. This score includes the following categories
- Conditions
- SARS Virus, SARS-CoV-2, COVID-19
- Being tested
- Convalescent SARS COVID-19 plasma, Placebo
- Keywords
- SARS Virus, SARS-CoV-2, COVID-19, Blood Plasma
- 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 SARS COVID-19 plasmaOther
Convalescent SARS COVID-19 plasma from a pool of 10 donor plasma. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician.
PlaceboOther
Single infusion of saline solution, in addition to standard care. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent SARS COVID-19 plasma | Experimental | Convalescent SARS COVID-19 plasma from a pool of 10 donor plasma, in addition to standard care. Receives: Other: Convalescent SARS COVID-19 plasma |
| Placebo | Placebo comparator | Single infusion of saline solution, in addition to standard care. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status during follow-up at 30th day
Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.
Measured: 30th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Secondary outcomes (13)
Clinical status during follow-up at 7th day
Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.
Measured: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Clinical status during follow-up at 14th day
Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.
Measured: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Time until hospital discharge (days).
Hospital discharge or intrahospital death
Measured: Whenever the patient is discharge from the hospital or die without discharge, through study completion, an average of 14 days from admission
Time until discharge from ICU (days)
ICU discharge or ICU death
Measured: Whenever the patient is discharge from ICU or die in ICU, through study completion, an average of 10 days from admission
Time to death
Death and time to death
Measured: In a 30 days follow up period
Time until complete functional recovery
Time until complete functional recovery (according to basal status).
Measured: Whenever the patient returns to basal functional status until 1 month from discharge
Percentage of participants with adverse events / serious adverse events
Percentage of participants with adverse events / serious adverse events
Measured: In a 30 days follow up period
Percentage of patients with negative SARS-CoV-3 PCR at Day 14th
Percentage of patients with negative SARS-CoV-3 PCR
Measured: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
D Dimer plasma concentration at Day 14th
D Dimer plasma concentration
Measured: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Ferritin plasma concentration at Day 13th
Ferritin plasma concentration
Measured: 13th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Plasma concentration of neutralizing antibodies at Day 2nd
Plasma concentration of neutralizing antibodies
Measured: 2nd Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Plasma concentration of neutralizing antibodies at Day 7th
Plasma concentration of neutralizing antibodies
Measured: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Post-transfusion adverse reactions
Post-transfusion adverse reactions between study groups
Measured: In a 30 days follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 May 2020
- Primary completion27 Sep 2020
- Study completion27 Sep 2020
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 SARS VirusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter randomized (2:1, 222 plasma 111 placebo), double-blind, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora A Fuentes, MD, Principal investigator, Hospital Privado de la Comunidad de Mar del PlataFlorencia Otermin, MD, Principal investigator, Hospital Italiano de la PlataEsteban Nannini, MD, Principal investigator, Sanatorio Britanico Rosario, pcia Santa FeKarina Rainiero, MD, Principal investigator, Suiza ArgentinaErica Miyazaki, MD, Principal investigator, Clinica ZabalaGabriela Vidiella, MD, Principal investigator, Sanatorio AgoteWanda Cornistein, MD, Principal investigator, Austral University, ArgentinaLeandro Burgos, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383535
- Sponsor's protocol ID
- 5565
- Acronym
- PLASM-AR
- Status last verified
- Sep 2020
- First submitted
- 6 May 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maiztegui JI, Fernandez NJ, de Damilano AJ. Efficacy of immune plasma in treatment of Argentine haemorrhagic fever and association between treatment and a late neurological syndrome. Lancet. 1979 Dec 8;2(8154):1216-7. doi: 10.1016/s0140-6736(79)92335-3.
PubMed 92624Tanne JH. Covid-19: FDA approves use of convalescent plasma to treat critically ill patients. BMJ. 2020 Mar 26;368:m1256. doi: 10.1136/bmj.m1256. No abstract available.
PubMed 32217555Shen 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 32219428Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.
PubMed 32219429Cheng 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 15616839Kalil AC. Treating COVID-19-Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics. JAMA. 2020 May 19;323(19):1897-1898. doi: 10.1001/jama.2020.4742. No abstract available.
PubMed 32208486Angus DC. Optimizing the Trade-off Between Learning and Doing in a Pandemic. JAMA. 2020 May 19;323(19):1895-1896. doi: 10.1001/jama.2020.4984. No abstract available.
PubMed 32227198Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. doi: 10.7326/0003-4819-145-8-200610170-00139. Epub 2006 Aug 29.
PubMed 16940336Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
PubMed 37162745Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
PubMed 36734509Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
PubMed 34013969Simonovich VA, Burgos Pratx LD, Scibona P, Beruto MV, Vallone MG, Vazquez C, Savoy N, Giunta DH, Perez LG, Sanchez MDL, Gamarnik AV, Ojeda DS, Santoro DM, Camino PJ, Antelo S, Rainero K, Vidiella GP, Miyazaki EA, Cornistein W, Trabadelo OA, Ross FM, Spotti M, Funtowicz G, Scordo WE, Losso MH, Ferniot I, Pardo PE, Rodriguez E, Rucci P, Pasquali J, Fuentes NA, Esperatti M, Speroni GA, Nannini EC, Matteaccio A, Michelangelo HG, Follmann D, Lane HC, Belloso WH; PlasmAr Study Group. A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. N Engl J Med. 2021 Feb 18;384(7):619-629. doi: 10.1056/NEJMoa2031304. Epub 2020 Nov 24.
PubMed 33232588
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial of Convalescent Plasma for the Treatment of COVID-19 Pneumonia With Severity Criteria
- ClinicalTrials.gov ID
- NCT04383535
- Acronym / sponsor ID
- PLASM-AR / 5565
- Conditions
- SARS Virus, SARS-CoV-2, COVID-19
- Keywords
- SARS Virus, SARS-CoV-2, COVID-19, Blood Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 27 Sep 2020 (actual)
- Study completion
- 27 Sep 2020 (actual)
- First posted
- 12 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.
A multicenter randomized, double-blind, placebo-controlled clinical trial of Convalescent SARS COVID-19 plasma versus Placebo to evaluate the effect between arms on an ordinal score of six mutually exclusive categories of clinical status at day 30 after study initiation.
Detailed description
Introduction
The use of convalescent plasma in the treatment of infectious diseases has been empirically performed for more than a century. It is based upon the assumption that providing exogenous neutralizing antibodies may provide protection while affected patients mount their own immune response. This therapeutic approach appears of particular interest in the context of the current pandemic, in which there is no specific vaccine available nor adequately proven effective pharmacological treatments.
Study purpose, hypothesis and general design
Purpose of the study: evaluate the effectiveness and safety of convalescent plasma in the treatment of SARS-CoV-2 pneumonia (Covid-19) Hypothesis: Convalescent plasma significantly improves the clinical outcome in patients with Covid-19 pneumonia and severity criteria.
Multicenter randomized, double-blind, placebo.controlled clinical trial. Placebo will be a saline solution.
- Methodological sustain for including a control arm with placebo Quality evidence about the effectiveness of convalescent plasma in the treatment of Covid-19 pneumonia is not yet available. Although case series and anecdotal reports appear encouraging, the implementation of its use in routine clinical practice requires the validation through controlled clinical trials. In addition the collection, administration and control of plasma is technically demanding and needs a clear support before broadly recommending it. Different scientific institutions and international organisms had clearly suggested to prioritize the application of novel therapeutic techniques with yet unproven efficacy within the context of clinical studies over its empirical use.
On the other hand, for the present study, intervention strategy is proposed in "add-on" modality over the antiviral treatment that each participant may be already receiving, since they represent completely different therapeutic approaches. As such, participation in the present study will not condition the possibility of the participants to receive other treatments, either in intervention or control arms.
- Study objectives Primary objective Analyze the difference between arms on an ordinal score of six mutually exclusive categories at day 30 after study initiation. This score includes the following categories
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
- Multicenter randomized (2:1, 222 plasma 111 placebo), double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Convalescent SARS COVID-19 plasma | Experimental | Other: Convalescent SARS COVID-19 plasmaConvalescent SARS COVID-19 plasma from a pool of 10 donor plasma, in addition to standard care. |
| Placebo | Placebo comparator | Other: PlaceboSingle infusion of saline solution, in addition to standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of Covid-19 through qualitative polymerase-reverse transcriptase (qRT-PCR -GeneDX Co, Ltd o similar).
- Imagining-diagnosed pneumonia (Rx or CT scan).
- MSOFA score (Modified SOFA) of 2 or more (modified organic failure assessment)
- Informed consent.
Key exclusion criteria (7 listed)
- Pregnant women
- Women at reproductive age not willing to avoid unprotected sexual intercourse up to Day 30 after study initiation.
- Women in the breastfeeding period
- Patients receiving experimental treatments under development within 30 days prior to study initiation.
- Patients with a previous history of allergic reactions to blood or blood-components transfusion.
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 SARS COVID-19 plasmaConvalescent SARS COVID-19 plasma from a pool of 10 donor plasma. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician. | Other | Convalescent SARS COVID-19 plasma |
| PlaceboSingle infusion of saline solution, in addition to standard care. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician. | Other | Placebo |
Primary outcome
Clinical status during follow-up at 30th day
Time frame: 30th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.
13 secondary outcomes
Clinical status during follow-up at 7th day
Time frame: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Clinical status during follow-up at 14th day
Time frame: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Time until hospital discharge (days).
Time frame: Whenever the patient is discharge from the hospital or die without discharge, through study completion, an average of 14 days from admission
Time until discharge from ICU (days)
Time frame: Whenever the patient is discharge from ICU or die in ICU, through study completion, an average of 10 days from admission
Time to death
Time frame: In a 30 days follow up period
Time until complete functional recovery
Time frame: Whenever the patient returns to basal functional status until 1 month from discharge
Percentage of participants with adverse events / serious adverse events
Time frame: In a 30 days follow up period
Percentage of patients with negative SARS-CoV-3 PCR at Day 14th
Time frame: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
D Dimer plasma concentration at Day 14th
Time frame: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Ferritin plasma concentration at Day 13th
Time frame: 13th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Plasma concentration of neutralizing antibodies at Day 2nd
Time frame: 2nd Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Plasma concentration of neutralizing antibodies at Day 7th
Time frame: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Post-transfusion adverse reactions
Time frame: In a 30 days follow up period
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 30 Sep 2020.
- Background: PubMed 92624Maiztegui JI, Fernandez NJ, de Damilano AJ. Efficacy of immune plasma in treatment of Argentine haemorrhagic fever and association between treatment and a late neurological syndrome. Lancet. 1979 Dec 8;2(8154):1216-7. doi: 10.1016/s0140-6736(79)92335-3.
- Background: PubMed 32217555Tanne JH. Covid-19: FDA approves use of convalescent plasma to treat critically ill patients. BMJ. 2020 Mar 26;368:m1256. doi: 10.1136/bmj.m1256. No abstract available.
- 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 32219429Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.
- Background: 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.
- Background: PubMed 32208486Kalil AC. Treating COVID-19-Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics. JAMA. 2020 May 19;323(19):1897-1898. doi: 10.1001/jama.2020.4742. No abstract available.
- Background: PubMed 32227198Angus DC. Optimizing the Trade-off Between Learning and Doing in a Pandemic. JAMA. 2020 May 19;323(19):1895-1896. doi: 10.1001/jama.2020.4984. No abstract available.
- Results publication: PubMed 16940336Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. doi: 10.7326/0003-4819-145-8-200610170-00139. Epub 2006 Aug 29.
- Derived from this study: PubMed 37162745Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
- Derived from this study: PubMed 36734509Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
- Derived from this study: PubMed 34013969Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
- Derived from this study: PubMed 33232588Simonovich VA, Burgos Pratx LD, Scibona P, Beruto MV, Vallone MG, Vazquez C, Savoy N, Giunta DH, Perez LG, Sanchez MDL, Gamarnik AV, Ojeda DS, Santoro DM, Camino PJ, Antelo S, Rainero K, Vidiella GP, Miyazaki EA, Cornistein W, Trabadelo OA, Ross FM, Spotti M, Funtowicz G, Scordo WE, Losso MH, Ferniot I, Pardo PE, Rodriguez E, Rucci P, Pasquali J, Fuentes NA, Esperatti M, Speroni GA, Nannini EC, Matteaccio A, Michelangelo HG, Follmann D, Lane HC, Belloso WH; PlasmAr Study Group. A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. N Engl J Med. 2021 Feb 18;384(7):619-629. doi: 10.1056/NEJMoa2031304. Epub 2020 Nov 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora A Fuentes, MD principal investigator
Hospital Privado de la Comunidad de Mar del Plata
Florencia Otermin, MD principal investigator
Hospital Italiano de la Plata
Esteban Nannini, MD principal investigator
Sanatorio Britanico Rosario, pcia Santa Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Convalescent SARS COVID-19 plasma in people with SARS Virus and SARS-CoV-2, run by Hospital Italiano de Buenos Aires 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 4 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: finished, as of the sponsor's last update on 30 Sep 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 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. 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.
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?
Clinical status during follow-up at 30th day (time frame: 30th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)). 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 NCT04383535, 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 30 Sep 2020.