Covid-19Phase 3NCT04432103
Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
A Phase 3 study testing Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients and Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients in people with Covid-19, run by Centro Medico ABC at 1 site in Mexico.
Trial summary
Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients and Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteMexico
- Study dates
- 8 Aug 2020to 29 Jan 2021
- Phase
- Phase 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
- Donors:
- Age: >18 and <60 years
- Body weight : >60 kg
- Confirmed previous SARS CoV-2 infection
- negative SARS CoV-2 test result
- 21 day without symptoms from the negative SARS CoV2 negative test
Show all 15Show fewer
- Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- Positive COVID-19 IgG antibodies
- Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
- Individuals who meet all regular voluntary donor eligibility requirements by the Mexican legislation.
- Patients/recipients:
- Age: >18 years
- Admitted to the ABC Medical Center facility for the treatment of COVID-19
- Patients with severe or critical COVID-19
- Informed consent provided by the patient or healthcare proxy
Who cannot join
- Patients/recipients:
- 1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. Any other not controlled infection 3. Disseminated Intravascular Coagulopathy 4. Patient under dialysis 5. Patient with recent Hemorrhagic Stroke 6. Severe Ischemic Heart Disease
- -
Trial locations and contacts
1 site in 1 country.
About this study
Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.
Read the detailed description
We will perform an open label two arms, non randomized trial giving Convalescent Plasma donated from recovered COVID-19 patients with positive serology to severe and clinical pneumonia COVID-19 patients admitted to the ABC Medical Center.
- Conditions
- Covid-19
- Being tested
- Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients, Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients
- Keywords
- covid-19, pneumonia, pandemic, convalescent plasma
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patientsBiological
Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 severe cases.
Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patientsBiological
Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 critical cases.
| Study group | Role | What they receive |
|---|---|---|
| Severe COVID-19 pneumonia | Experimental | Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma Receives: Biological: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients |
| Critical COVID- 19 pneumonia | Experimental | Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma Receives: Biological: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
INCIDENCE OF CRITICAL PNEUMONIA
progression to critical stage
Measured: 14 days after convalescent plasma administration
MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS
mortality
Measured: 28 days after convalescent plasma administration
Secondary outcomes (2)
INCIDENCE OF MECHANICAL VENTILATION
time to need mechanical ventilation
Measured: 14 days after convalescent plasma treatment
DAYS OF MECHANICAL VENTILATION
time of mechanical ventilation needed
Measured: 28 days after convalescent plasma treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start8 Aug 2020
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Why it stopped: There is new evidence that the Convalescent plasma is not useful for severe and critical COVID-19 Pneumonia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups depending on the stage of the disease according to the CDC of China classification severe and critical COVID-19 pneumonia
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Moreno, MD, Principal investigator, ABC Medical Center Internal Medicine Department. Mexico City, MexicoIrma Hoyo, MD PHD, Principal investigator, ABC Medical Center Internal Medicine Department. Mexico City, MexicoBenjamín Valente, MD MSc DTMH, Principal investigator, ABC Medical Center Internal Medicine Department. Mexico City, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432103
- Sponsor's protocol ID
- ABC-20-14
- Status last verified
- Jul 2021
- First submitted
- 12 Jun 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.
PubMed 32015508van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
PubMed 32182409Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.
PubMed 32074444Burke RM, Midgley CM, Dratch A, Fenstersheib M, Haupt T, Holshue M, Ghinai I, Jarashow MC, Lo J, McPherson TD, Rudman S, Scott S, Hall AJ, Fry AM, Rolfes MA. Active Monitoring of Persons Exposed to Patients with Confirmed COVID-19 - United States, January-February 2020. MMWR Morb Mortal Wkly Rep. 2020 Mar 6;69(9):245-246. doi: 10.15585/mmwr.mm6909e1.
PubMed 32134909Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.
PubMed 32083643Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available.
PubMed 32003551Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
PubMed 32015507Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PubMed 31995857Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10.
PubMed 32150748Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Liu K, Fang YY, Deng Y, Liu W, Wang MF, Ma JP, Xiao W, Wang YN, Zhong MH, Li CH, Li GC, Liu HG. Clinical characteristics of novel coronavirus cases in tertiary hospitals in Hubei Province. Chin Med J (Engl). 2020 May 5;133(9):1025-1031. doi: 10.1097/CM9.0000000000000744.
PubMed 32044814
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
- ClinicalTrials.gov ID
- NCT04432103
- Acronym / sponsor ID
- ABC-20-14
- Conditions
- Covid-19
- Keywords
- covid-19, pneumonia, pandemic, convalescent plasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is new evidence that the Convalescent plasma is not useful for severe and critical COVID-19 Pneumonia
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centro Medico ABCUniversity, hospital or other
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 16 Jun 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.
Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.
Detailed description
We will perform an open label two arms, non randomized trial giving Convalescent Plasma donated from recovered COVID-19 patients with positive serology to severe and clinical pneumonia COVID-19 patients admitted to the ABC Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups depending on the stage of the disease according to the CDC of China classification severe and critical COVID-19 pneumonia
| Arm | Type | Receives |
|---|---|---|
| Severe COVID-19 pneumonia | Experimental | Biological: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patientsHospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma |
| Critical COVID- 19 pneumonia | Experimental | Biological: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patientsHospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age: >18 and <60 years
- Body weight : >60 kg
- Confirmed previous SARS CoV-2 infection
- negative SARS CoV-2 test result
- 21 day without symptoms from the negative SARS CoV2 negative test
Key exclusion criteria (3 listed)
- 1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. Any other not controlled infection 3. Disseminated Intravascular Coagulopathy 4. Patient under dialysis 5. Patient with recent Hemorrhagic Stroke 6. Severe Ischemic Heart Disease
- -
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 |
|---|---|---|
| Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patientsAdministration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 severe cases. | Biological | Severe COVID-19 pneumonia |
| Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patientsAdministration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 critical cases. | Biological | Critical COVID- 19 pneumonia |
Primary outcome
INCIDENCE OF CRITICAL PNEUMONIA
Time frame: 14 days after convalescent plasma administration
progression to critical stage
MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS
Time frame: 28 days after convalescent plasma administration
mortality
2 secondary outcomes
INCIDENCE OF MECHANICAL VENTILATION
Time frame: 14 days after convalescent plasma treatment
DAYS OF MECHANICAL VENTILATION
Time frame: 28 days after convalescent plasma treatment
Results and safety
The study was stopped early (reason given: There is new evidence that the Convalescent plasma is not useful for severe and critical COVID-19 Pneumonia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Results publication: PubMed 32015508Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.
- Results publication: PubMed 32182409van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
- Results publication: PubMed 32074444Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.
- Results publication: PubMed 32134909Burke RM, Midgley CM, Dratch A, Fenstersheib M, Haupt T, Holshue M, Ghinai I, Jarashow MC, Lo J, McPherson TD, Rudman S, Scott S, Hall AJ, Fry AM, Rolfes MA. Active Monitoring of Persons Exposed to Patients with Confirmed COVID-19 - United States, January-February 2020. MMWR Morb Mortal Wkly Rep. 2020 Mar 6;69(9):245-246. doi: 10.15585/mmwr.mm6909e1.
- Results publication: PubMed 32083643Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.
- Results publication: PubMed 32003551Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available.
- Results publication: PubMed 32015507Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
- Results publication: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Results publication: PubMed 31995857Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
- Results publication: PubMed 32150748Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10.
- Results publication: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Results publication: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- WHO Director-General's remarks at the media briefing on 2019-nCoV on 11 February 2020 \[Internet\]. \[cited 2020 Mar 23\].Link provided by the sponsor.
- Johns Hopkins Coronavirus Resource Center \[Internet\]. Johns Hopkins Coronavirus Resource Center. \[cited 2020 Mar 23\].Link provided by the sponsor.
- Situation update worldwide, as of 22 March 2020 \[Internet\]. European Centre for Disease Prevention and Control. \[cited 2020 Mar 23\]Link provided by the sponsor.
- Novel Coronavirus (2019-nCoV) situation reports \[Internet\]. \[cited 2020 Mar 23\].Link provided by the sponsor.
- who-china-joint-mission-on-covid-19-final-report.pdf \[Internet\]. \[cited 2020 Mar 23\].Link provided by the sponsor.
- CDC. Coronavirus Disease 2019 (COVID-19) \[Internet\]. Centers for Disease Control and Prevention. 2020 \[cited 2020 Apr 7\].Link provided by the sponsor.
- 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.
Francisco Moreno, MD principal investigator
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Irma Hoyo, MD PHD principal investigator
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Benjamín Valente, MD MSc DTMH principal investigator
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients and Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients in people with Covid-19, run by Centro Medico ABC at 1 site 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 15 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: stopped early, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 phase mean?
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 was stopped early (reason given: There is new evidence that the Convalescent plasma is not useful for severe and critical COVID-19 Pneumonia). Results are not available in the source record.
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?
INCIDENCE OF CRITICAL PNEUMONIA (time frame: 14 days after convalescent plasma administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04432103, which also lists 34 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 2 Aug 2021.