Covid19Phase 2NCT04513158
Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
A Phase 2 study testing Convalescent Plasma in people with Covid19, run by Joseph M. Flynn, D.O., MPH at 4 sites in United States.
Trial summary
This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid19
- What is being tested?
- Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Aug 2020to 28 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing.
- Patients must also have the following indications for enrollment:
- i. D-Dimer > 500 ng/ml FEU OR
- ii. IL-6> 5 pg/mL
- With any of the following:
- iii. Lymphocytes < 0.8 103/ul OR
Show all 22Show fewer
- iv. LDH > 700 U/L OR
- v. CK > 170 U/L OR
- vi. CRP > 1.0 mg/dl OR
- vii. Ferritin > 1000 ng/ml
- AND one of the following:
- viii. Age over 60 years
- ix. Underlying Active Malignancy
- x. Cardiovascular Disease
- xi. Active Tobacco Use
- xii. History of Pulmonary Volume Reduction Surgery
- xiii. Hypertension
- Prior Treatment: Patients are still eligible for this trial if active antimicrobial agents are in use. Patients are also eligible if they had been treated on COVID-19 clinical trial in the course of their disease.
- Age ≥ 18 years.
- The effects of allogeneic plasma infusion on the developing fetus is unknown. For this reason women who are pregnant are not eligible to participate.
- Agrees to required laboratory data collected which will include the baseline organ function and regular ongoing assessments done as part of routine care.
- Ability to understand and the willingness to sign a written informed consent document or ability to have consent provided by Legally Authorized Representative.
Who cannot join
- 4.2.1 Patients who do not meet above inclusion criteria are not eligible.
- 4.2.2 Patients may not be receiving any other investigational agents.
- 4.2.3 History of allergic reactions attributed to previous transfusion history.
- 4.2.4 Respiratory rate >30/min
- 4.2.5 Blood oxygen saturation <93%
- 4.2.6 Partial pressure of arterial oxygen to fraction of inspired oxygen ration <300
- 4.2.7 Diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Norton Hospital
Louisville, Kentucky, 40202
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207
Norton Audubon Hospital
Louisville, Kentucky, 40217
Norton Brownsboro Hospital
Louisville, Kentucky, 40241
About this study
This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
Read the detailed description
Following the administration of one unit (approximately 200 mL) of convalescent plasma over one hour, the study proposes to determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) by prevention of progression to severe or life threatening COVID-19 during the current hospitalization as determined by evaluating if the patient experienced the following the following: respiratory rate >30/min, Blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300, or received a medical diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure. This will be captured from the daily physical exam/clinical assessment done as part of routine care and at discharge.
The study also proposes to determine the immunologic effects of convalescent plasma infusion as measured by serial SARS-CoV-2 Ag levels through RT-PCR measured by CoV PCR collected at enrollment, day 7 and discharge.
Finally, the study intends to measure normalization of laboratory parameters for risk which will be documented every 3 days while the patient is hospitalized until the time that lab value returns to within the institution's normal range.
- Conditions
- Covid19
- Being tested
- Convalescent Plasma
- Keywords
- SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaBiological
Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results. Receives: Biological: Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).
Measured by respiratory rate >30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300 and received a medical diagnosis of respiratory failure, septic shock or multiple
Measured: Through study completion, an average of 30 days
Secondary outcomes (7)
Determine the Immunologic Effects of Convalescent Plasma Infusion
SARS-CoV-2 Ag levels through RT-PCR
Measured: Through study completion, an average of 14 days
Absolute Lymphocyte Count (10*3/uL)
Measure normalization of laboratory parameters for risk
Measured: Through study completion, an average of 14 days
Reatinine Kinase (mg/dL)
Measure normalization of laboratory parameters for risk
Measured: Through study completion, an average of 14 days
C-reactive Protein (mg/dl)
Measure normalization of laboratory parameters for risk
Measured: Through study completion, an average of 14 days
D-Dimer (ng/ml FEU)
Measure normalization of laboratory parameters for risk
Measured: Through study completion, an average of 14 days
Interleukin-6 (pg/ml)
Measure normalization of laboratory parameters for risk
Measured: Through study completion, an average of 14 days
Ferritin (ng/mL)
Measure normalization of laboratory parameters for risk
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start14 Aug 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Why it stopped: Newly reported data at the time indicated that alternative therapies were more effective than CP for early treatment of high-risk patients with COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All hospitalized patients meeting study inclusion/exclusion criteria and providing informed consent for participation in the study will receive one unit (approximately 200 mL) of convalescent plasma over one hour to with data collection of routine physical exams/clinical assessments (daily) and routine lab results (every 3 days).
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph M. Flynn, D.O., MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph M. Flynn, D.O., MPH, Norton Healthcare
- Investigators
- Joseph M Flynn, DO, MPH, Principal investigator, Norton Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513158
- Sponsor's protocol ID
- 20-N0124
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2020
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu 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 32091533Bonow RO, Fonarow GC, O'Gara PT, Yancy CW. Association of Coronavirus Disease 2019 (COVID-19) With Myocardial Injury and Mortality. JAMA Cardiol. 2020 Jul 1;5(7):751-753. doi: 10.1001/jamacardio.2020.1105. No abstract available.
PubMed 32219362Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
PubMed 32179124Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. The Epidemiological Characteristics of an Outbreak of 2019 Novel Coronavirus Diseases (COVID-19) - China, 2020. China CDC Wkly. 2020 Feb 21;2(8):113-122. No abstract available.
PubMed 34594836Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.
PubMed 32221519Jean SS, Lee PI, Hsueh PR. Treatment options for COVID-19: The reality and challenges. J Microbiol Immunol Infect. 2020 Jun;53(3):436-443. doi: 10.1016/j.jmii.2020.03.034. Epub 2020 Apr 4.
PubMed 32307245Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
PubMed 32227758Baron SA, Devaux C, Colson P, Raoult D, Rolain JM. Teicoplanin: an alternative drug for the treatment of COVID-19? Int J Antimicrob Agents. 2020 Apr;55(4):105944. doi: 10.1016/j.ijantimicag.2020.105944. Epub 2020 Mar 13.
PubMed 32179150Mair-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 25030060Lim VW, Tudor Car L, Leo YS, Chen MI, Young B. Passive immune therapy and other immunomodulatory agents for the treatment of severe influenza: Systematic review and meta-analysis. Influenza Other Respir Viruses. 2020 Mar;14(2):226-236. doi: 10.1111/irv.12699. Epub 2019 Nov 16.
PubMed 31733048Cheng 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 15616839van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.
PubMed 26735992Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.
PubMed 26618098
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
- ClinicalTrials.gov ID
- NCT04513158
- Acronym / sponsor ID
- 20-N0124
- Conditions
- Covid19
- Keywords
- SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Newly reported data at the time indicated that alternative therapies were more effective than CP for early treatment of high-risk patients with COVID-19.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Joseph M. Flynn, D.O., MPHUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
Detailed description
Following the administration of one unit (approximately 200 mL) of convalescent plasma over one hour, the study proposes to determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) by prevention of progression to severe or life threatening COVID-19 during the current hospitalization as determined by evaluating if the patient experienced the following the following: respiratory rate >30/min, Blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300, or received a medical diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure. This will be captured from the daily physical exam/clinical assessment done as part of routine care and at discharge.
The study also proposes to determine the immunologic effects of convalescent plasma infusion as measured by serial SARS-CoV-2 Ag levels through RT-PCR measured by CoV PCR collected at enrollment, day 7 and discharge.
Finally, the study intends to measure normalization of laboratory parameters for risk which will be documented every 3 days while the patient is hospitalized until the time that lab value returns to within the institution's normal range.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All hospitalized patients meeting study inclusion/exclusion criteria and providing informed consent for participation in the study will receive one unit (approximately 200 mL) of convalescent plasma over one hour to with data collection of routine physical exams/clinical assessments (daily) and routine lab results (every 3 days).
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: Convalescent PlasmaStudy is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing.
- Patients must also have the following indications for enrollment:
- i. D-Dimer > 500 ng/ml FEU OR
- ii. IL-6> 5 pg/mL
- iii. Lymphocytes < 0.8 103/ul OR
Key exclusion criteria (7 listed)
- 4.2.1 Patients who do not meet above inclusion criteria are not eligible.
- 4.2.2 Patients may not be receiving any other investigational agents.
- 4.2.3 History of allergic reactions attributed to previous transfusion history.
- 4.2.4 Respiratory rate >30/min
- 4.2.5 Blood oxygen saturation <93%
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 PlasmaPlasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent. | Biological | Treatment Arm |
Primary outcome
Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).
Time frame: Through study completion, an average of 30 days
Measured by respiratory rate >30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300 and received a medical diagnosis of respiratory failure, septic shock or multiple
7 secondary outcomes
Determine the Immunologic Effects of Convalescent Plasma Infusion
Time frame: Through study completion, an average of 14 days
Absolute Lymphocyte Count (10*3/uL)
Time frame: Through study completion, an average of 14 days
Reatinine Kinase (mg/dL)
Time frame: Through study completion, an average of 14 days
C-reactive Protein (mg/dl)
Time frame: Through study completion, an average of 14 days
D-Dimer (ng/ml FEU)
Time frame: Through study completion, an average of 14 days
Interleukin-6 (pg/ml)
Time frame: Through study completion, an average of 14 days
Ferritin (ng/mL)
Time frame: Through study completion, an average of 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Background: PubMed 32219362Bonow RO, Fonarow GC, O'Gara PT, Yancy CW. Association of Coronavirus Disease 2019 (COVID-19) With Myocardial Injury and Mortality. JAMA Cardiol. 2020 Jul 1;5(7):751-753. doi: 10.1001/jamacardio.2020.1105. No abstract available.
- Background: PubMed 32179124Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 34594836The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. The Epidemiological Characteristics of an Outbreak of 2019 Novel Coronavirus Diseases (COVID-19) - China, 2020. China CDC Wkly. 2020 Feb 21;2(8):113-122. No abstract available.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 32221519Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.
- Background: PubMed 32307245Jean SS, Lee PI, Hsueh PR. Treatment options for COVID-19: The reality and challenges. J Microbiol Immunol Infect. 2020 Jun;53(3):436-443. doi: 10.1016/j.jmii.2020.03.034. Epub 2020 Apr 4.
- Background: PubMed 32227758Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
- Background: PubMed 32179150Baron SA, Devaux C, Colson P, Raoult D, Rolain JM. Teicoplanin: an alternative drug for the treatment of COVID-19? Int J Antimicrob Agents. 2020 Apr;55(4):105944. doi: 10.1016/j.ijantimicag.2020.105944. Epub 2020 Mar 13.
- Background: 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.
- Background: PubMed 31733048Lim VW, Tudor Car L, Leo YS, Chen MI, Young B. Passive immune therapy and other immunomodulatory agents for the treatment of severe influenza: Systematic review and meta-analysis. Influenza Other Respir Viruses. 2020 Mar;14(2):226-236. doi: 10.1111/irv.12699. Epub 2019 Nov 16.
- 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.
Joseph M Flynn, DO, MPH principal investigator
Norton Healthcare
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Convalescent Plasma in people with Covid19, run by Joseph M. Flynn, D.O., MPH at 4 sites in United States.
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 22 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: stopped early, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19). (time frame: Through study completion, an average of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04513158, which also lists 39 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 24 Oct 2024.