COVID-19Phase 1/2COPLASCOV19NCT04356482
CONVALESCENT PLASMA FOR ILL PATIENTS BY COVID-19
A Phase 1/2 study testing convalescent plasma in people with COVID-19 and SARS-CoV 2, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 3 sites in Mexico.
Trial summary
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID-19, SARS-CoV 2, Convalescence
- What is being tested?
- convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesMexico
- Study dates
- 20 May 2020to Dec 2020
- Phase
- Phase 1/2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with COVID-19 test positive and... Severe ill patient
- Respiratory difficulty
- Sat O2 <93% without O2 but improves with the use of supplemental oxygen
- CT scan image: COVID-19 compatible pneumonia
- one or more of at least: SOFA = 0 D-dimer ≥500 Age ≥ 65 years Comorbidities such as high blood pressure, diabetes mellitus type I and II, chronic kidney failure, controlled or cured cancer, ≥ 1 degree of obesity
- Very severe ill:
Show all 12Show fewer
- Respiratory difficulty that does not improve with supplemental oxygen, requiring intubation and connecting to ventilatory support of no more than 72hrs or 3 days.
- CT image: COVID-19 compatible pneumonia
- one or more of at least: SOFA ≥1 Dimer D ≥ 750 Age ≥ 65 years Comorbidities such as hypertension, diabetes mellitus type I and II, Chronic Kidney Failure, Controlled or cured cancer, ≥ 1 degree of obesity.
- Survival over 5 days.
- Other inclusion criteria:
- Pregnant women are accepted
Who cannot join
- patients with asymptomatic/mild disease for COVID-19
- Children less than 16 years old
- patients with atypical pneumonia without COVID-19 diagnostic for PCR-RT
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites, 3 recruiting
- Not yet recruiting
Hospital Del Issste Regional En Guadalajara Jalisco
Guadalajara, Jalisco, 45100
CARLOS BEST, MD, +523310722818, carlosbest@gmail.com
- Not yet recruiting
Secretaria de Salud Del Estado de Sonora, Hospital General Del Estado
Hermosillo, Sonora, 64890
LUIS villela, MD, +526624756529, luisvillela@yahoo.com
Melani Otañez, MD, +526629374833, otanezmelani@gmail.com
- Recruiting
Hospital Central Norte Pemex
Mexico City, 02720
FERNANDO PEREZ-JACOBO, MD, +525540821871, fernando.perez.jacobo@hotmail.com
About this study
Official title: DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients.
Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria.
Read more
So, our hypotheses are:
- Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19?
- the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?
Read the detailed description
Specific objectives
- Show the efficacy and safety of fresh plasma in different doses in severe cases and in very severe cases.
- Assess whether fresh plasma can overcome negative prognostic factors in very severe ill patients with COVID-19 infection. These factors are age, high SOFA score, and high D-dimer.
- To evaluate the titration of antiCOVID-19 antibodies and if its quantification is related to the therapeutic response.
The responses to drug treatments that exist in our country such as hydroxychloroquine ± azithromycin, lopinavir / ritonavir and tocilizumab (anti-IL-6) are very heterogeneous, with high cost and diverse and serious adverse events in some cases. Absent randomized-controlled studies and case series or small cohort studies have not been shown to be more effective than supportive treatments in these patients. One more factor is that intubated patients cannot swallow and these medications are for oral posology; the only way to administer is through a nasogastric tube, so we cannot assure that its absorption is as expected and that the blood levels do not reach therapeutic levels.
Therefore, we propose a treatment that in the first instance is in our hands, which has already proven to be effective in infection with highly pathogenic viruses such as Ebola virus, Lassar fever and other coronavirus infections (SARS1 in 2003, MERS 2012). With regard to convalescent plasma, two studies have recently been published, a series of 5 and another of 10 cases, seriously ill and with no response to the mentioned therapies (hydroxychloroquine ± azithromycin and lopinavir / ritonavir, among others). The outcomes in this series of cases have been reported satisfactory in most with few minimal adverse events (rash).
Since the convalescent plasma dose is very ambiguous in the case-series reported, we will try to find this dose. Therefore, in this initial phase, we divided it into two severity groups:
- . Severe ill group, convalescent plasma dose on day 0, evaluation on day +3 and if you continue with the clinic and laboratories, a second dose of plasma may be administered. Always watching the safety always (early and late transfusion reactions). Clinical evaluation (including oxygenation) as well as laboratory (days +6, +9, +12, +15, +18, +21 to find the necessary dose for response. The patients will be evaluated and if they meet the response points, the minimum effective plasma dose will be recommended for phase 2.
- . Very severe ill group, convalescent plasma dose day 0, with evaluation on day +3, will add another dose of plasma if there is no improvement clinic or laboratory, reevaluate day +6 and if required, apply another dose of plasma if there will be not clinical or laboratory improvement. Always watching security. It is reassessed clinically (including respiratory parameters) on days +9, +12, +15, +18 and +21, to find the minimal dose necessary. This sequential treatment will help reduce the risk of water overload and also assess the presence of transfusion lung injury syndrome or TRALI. A second phase, the dose and safety of treatment will be evaluated.
In the second phase , both early and late or B will be evaluated as follows:
to. Sever ill cases: plasma will be applied according to the dose you will find in phase 1b. Security and response will be evaluated in this phase.
- Very sever ill cases: Plasma will be applied according to the dose you will find in phase 1b and the safety and response phase will be evaluated.
It will also be open (the study will not be blinded), it will not be randomized, and it will be controlled only by the severity of the patient and their characteristics of the disease (severe vs. very severe), as well as being controlled by the amount of infusion of plasma (minimum effective dose).
SECURITY ANALYSIS
The security analysis will be between the researchers in the group and another externak group. They will analyze the first 5 patients in each group (severe and very severe), the main objective for security analysis is going to be mortality related directly to plasma infusion. Subsequently, every 20 patients in each group for phase 2 will be analyzed for safety and response.
- Conditions
- COVID-19, SARS-CoV 2, Convalescence, Plasma, Doses
- Being tested
- convalescent plasma
- Keywords
- covid-19, convalescent plasma doses, sars-Cov 2, treatment, response
- Medical subject headings
- COVID-19, Convalescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
convalescent plasmaBiological
Also called no apply
In phase 1, different amounts of convalescent plasma will be evaluated depending on the severity of the case.
In phase 2, both clinical, laboratory, imaging and viral presence (effectiveness) and safety will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Determine the convalescent plasma dose to be administered to two groups: one severely ill (not intubated) and one very severely ill (intubated).
Second phase: safety and efficacy of the plasma dose found in the same two types of patients. Receives: Biological: convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement.
Measured: day -1 to day +22
improvement in tomographic image
before convalescent plasma infusion, the CT image will be compared and subsequently the evolution of images in the CT will be evaluated every 72 hours on 3 times .
Measured: day -1 to day +12
test positivity for COVID-19
the patients will be evaluated on three occasions the positivity of the test (PCR-RT). If two of them are negative, it will be defined as a virus-free patient.
Measured: day +6 to day +12
early and late complications associated to convalescent plasma
Patients will be evaluated for adverse events during the plasma infusion up to 30 days after that. Especially mild and severe allergic reactions (anaphylaxis), other issues like TRALI.
Measured: day 0 to day +30
Secondary outcomes (1)
days at ICU
days of stay at ICU will be evaluated
Measured: day 0 to day +30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start20 May 2020
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Sponsor type
- Other government
- Collaborators
- SECRETARIA DE SALUD DEL ESTADO DE SONORA, CENTRO ESTATAL DE LA TRANSFUSION SANGUINEA, HOSPITAL CENTRAL NACIONAL PEMEX NORTE, HOSPITAL DE ZONA No. 2 IMSS, HOSPITAL DE ZONA No.14 IMSS, HOSPITAL GENERAL DEL ESTADO DE SONORA
- Responsible party
- Principal investigator, Luis Villela, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Investigators
- Luis M Villela, MD, Principal investigator, ISSSTESON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356482
- Sponsor's protocol ID
- TERAPLASCOV2
- Acronym
- COPLASCOV19
- Status last verified
- Jun 2020
- First submitted
- 17 Apr 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 32253318Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
PubMed 32125452Rajam G, Sampson J, Carlone GM, Ades EW. An augmented passive immune therapy to treat fulminant bacterial infections. Recent Pat Antiinfect Drug Discov. 2010 Jun;5(2):157-67. doi: 10.2174/157489110791233496.
PubMed 20370679Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev. 2000 Oct;13(4):602-14. doi: 10.1128/CMR.13.4.602.
PubMed 11023960Burnouf T, Seghatchian J. Ebola virus convalescent blood products: where we are now and where we may need to go. Transfus Apher Sci. 2014 Oct;51(2):120-5. doi: 10.1016/j.transci.2014.10.003.
PubMed 25457751Jahrling PB, Frame JD, Rhoderick JB, Monson MH. Endemic Lassa fever in Liberia. IV. Selection of optimally effective plasma for treatment by passive immunization. Trans R Soc Trop Med Hyg. 1985;79(3):380-4. doi: 10.1016/0035-9203(85)90388-8.
PubMed 3898484Shen 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19
- ClinicalTrials.gov ID
- NCT04356482
- Acronym / sponsor ID
- COPLASCOV19 / TERAPLASCOV2
- Conditions
- COVID-19, SARS-CoV 2, Convalescence, Plasma, Doses
- Keywords
- covid-19, convalescent plasma doses, sars-Cov 2, treatment, response
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoOther government
- Collaborators
- SECRETARIA DE SALUD DEL ESTADO DE SONORA, CENTRO ESTATAL DE LA TRANSFUSION SANGUINEA, HOSPITAL CENTRAL NACIONAL PEMEX NORTE, HOSPITAL DE ZONA No. 2 IMSS, HOSPITAL DE ZONA No.14 IMSS, HOSPITAL GENERAL DEL ESTADO DE SONORA
- Study start
- 20 May 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Apr 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.
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients.
Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria.
So, our hypotheses are:
- Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19?
- the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?
Detailed description
Specific objectives
- Show the efficacy and safety of fresh plasma in different doses in severe cases and in very severe cases.
- Assess whether fresh plasma can overcome negative prognostic factors in very severe ill patients with COVID-19 infection. These factors are age, high SOFA score, and high D-dimer.
- To evaluate the titration of antiCOVID-19 antibodies and if its quantification is related to the therapeutic response.
The responses to drug treatments that exist in our country such as hydroxychloroquine ± azithromycin, lopinavir / ritonavir and tocilizumab (anti-IL-6) are very heterogeneous, with high cost and diverse and serious adverse events in some cases. Absent randomized-controlled studies and case series or small cohort studies have not been shown to be more effective than supportive treatments in these patients. One more factor is that intubated patients cannot swallow and these medications are for oral posology; the only way to administer is through a nasogastric tube, so we cannot assure that its absorption is as expected and that the blood levels do not reach therapeutic levels.
Therefore, we propose a treatment that in the first instance is in our hands, which has already proven to be effective in infection with highly pathogenic viruses such as Ebola virus, Lassar fever and other coronavirus infections (SARS1 in 2003, MERS 2012). With regard to convalescent plasma, two studies have recently been published, a series of 5 and another of 10 cases, seriously ill and with no response to the mentioned therapies (hydroxychloroquine ± azithromycin and lopinavir / ritonavir, among others). The outcomes in this series of cases have been reported satisfactory in most with few minimal adverse events (rash).
Since the convalescent plasma dose is very ambiguous in the case-series reported, we will try to find this dose. Therefore, in this initial phase, we divided it into two severity groups:
- . Severe ill group, convalescent plasma dose on day 0, evaluation on day +3 and if you continue with the clinic and laboratories, a second dose of plasma may be administered. Always watching the safety always (early and late transfusion reactions). Clinical evaluation (including oxygenation) as well as laboratory (days +6, +9, +12, +15, +18, +21 to find the necessary dose for response. The patients will be evaluated and if they meet the response points, the minimum effective plasma dose will be recommended for phase 2.
- . Very severe ill group, convalescent plasma dose day 0, with evaluation on day +3, will add another dose of plasma if there is no improvement clinic or laboratory, reevaluate day +6 and if required, apply another dose of plasma if there will be not clinical or laboratory improvement. Always watching security. It is reassessed clinically (including respiratory parameters) on days +9, +12, +15, +18 and +21, to find the minimal dose necessary. This sequential treatment will help reduce the risk of water overload and also assess the presence of transfusion lung injury syndrome or TRALI. A second phase, the dose and safety of treatment will be evaluated.
In the second phase , both early and late or B will be evaluated as follows:
to. Sever ill cases: plasma will be applied according to the dose you will find in phase 1b. Security and response will be evaluated in this phase.
- Very sever ill cases: Plasma will be applied according to the dose you will find in phase 1b and the safety and response phase will be evaluated.
It will also be open (the study will not be blinded), it will not be randomized, and it will be controlled only by the severity of the patient and their characteristics of the disease (severe vs. very severe), as well as being controlled by the amount of infusion of plasma (minimum effective dose).
SECURITY ANALYSIS
The security analysis will be between the researchers in the group and another externak group. They will analyze the first 5 patients in each group (severe and very severe), the main objective for security analysis is going to be mortality related directly to plasma infusion. Subsequently, every 20 patients in each group for phase 2 will be analyzed for safety and response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: convalescent plasmaDetermine the convalescent plasma dose to be administered to two groups: one severely ill (not intubated) and one very severely ill (intubated). Second phase: safety and efficacy of the plasma dose found in the same two types of patients. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- All patients with COVID-19 test positive and... Severe ill patient
- Respiratory difficulty
- Sat O2 <93% without O2 but improves with the use of supplemental oxygen
- CT scan image: COVID-19 compatible pneumonia
- one or more of at least: SOFA = 0 D-dimer ≥500 Age ≥ 65 years Comorbidities such as high blood pressure, diabetes mellitus type I and II, chronic kidney failure, controlled or cured cancer, ≥ 1 degree of obesity
Key exclusion criteria (3 listed)
- patients with asymptomatic/mild disease for COVID-19
- Children less than 16 years old
- patients with atypical pneumonia without COVID-19 diagnostic for PCR-RT
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 plasmaAlso: no applyIn phase 1, different amounts of convalescent plasma will be evaluated depending on the severity of the case. In phase 2, both clinical, laboratory, imaging and viral presence (effectiveness) and safety will be evaluated. | Biological | single arm |
Primary outcome
Clinical improvement
Time frame: day -1 to day +22
no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement.
improvement in tomographic image
Time frame: day -1 to day +12
before convalescent plasma infusion, the CT image will be compared and subsequently the evolution of images in the CT will be evaluated every 72 hours on 3 times .
test positivity for COVID-19
Time frame: day +6 to day +12
the patients will be evaluated on three occasions the positivity of the test (PCR-RT). If two of them are negative, it will be defined as a virus-free patient.
early and late complications associated to convalescent plasma
Time frame: day 0 to day +30
Patients will be evaluated for adverse events during the plasma infusion up to 30 days after that. Especially mild and severe allergic reactions (anaphylaxis), other issues like TRALI.
1 secondary outcome
days at ICU
Time frame: day 0 to day +30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- 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.
- Results publication: PubMed 32125452Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
- Results publication: PubMed 20370679Rajam G, Sampson J, Carlone GM, Ades EW. An augmented passive immune therapy to treat fulminant bacterial infections. Recent Pat Antiinfect Drug Discov. 2010 Jun;5(2):157-67. doi: 10.2174/157489110791233496.
- Results publication: PubMed 11023960Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev. 2000 Oct;13(4):602-14. doi: 10.1128/CMR.13.4.602.
- Results publication: PubMed 25457751Burnouf T, Seghatchian J. Ebola virus convalescent blood products: where we are now and where we may need to go. Transfus Apher Sci. 2014 Oct;51(2):120-5. doi: 10.1016/j.transci.2014.10.003.
- Results publication: PubMed 3898484Jahrling PB, Frame JD, Rhoderick JB, Monson MH. Endemic Lassa fever in Liberia. IV. Selection of optimally effective plasma for treatment by passive immunization. Trans R Soc Trop Med Hyg. 1985;79(3):380-4. doi: 10.1016/0035-9203(85)90388-8.
- Results publication: 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.
- 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.
Luis M Villela, MD principal investigator
ISSSTESON
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing convalescent plasma in people with COVID-19 and SARS-CoV 2, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 3 sites in Mexico.
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 12 inclusion and 3 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 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis M Villela, MD (+526624756529, luisvillela@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: day -1 to day +22). The study lists 4 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 NCT04356482, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.