COVID-19NCT04358211
Expanded Access to Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19
A study testing Biological: COVID-19 convalescent plasma in people with COVID-19, run by Nakhle Saba, MD at 1 site in United States.
Trial summary
I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in 1. intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT. 2. 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?
- Biological: COVID-19 convalescent plasma
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Population 1: Associated Severe Pulmonary Complications
- 18 years or older.
- Hospitalized and intubated in the ICU with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements, or requirement for informed consent is WAIVED due to the inability to communicate with the patient and unable to identify legally authorized representative.
- Consents to storage of specimens for future testing, or consent waived.
- The requirements to waive a consent are delineated in 21 CFR 50.23 and will be followed.
- Pregnant and breastfeeding women will not be excluded from the study.
Show all 10Show fewer
- Population 2: Coronavirus Associated Complications in hospitalized patients
- Patients must be 18 years of age or older.
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
- Patient agrees to storage of specimens for future testing.
Who cannot join
- Population 1:
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- Severe multi-organ failure with expected life expectancy < 24h as determined by the treating physician.
- Population 2:
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- Receipt of pooled immunoglobulin in past 30 days.
- Contraindication to transfusion or history of prior reactions to transfusion blood products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19
- Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in
- intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT.
- hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19.
II. Study Population:
Read more
- Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older.
- Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness.
III. Study Agent:
SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL at neutralization antibody titer >1:160.
Read the detailed description
There are currently no proven safe and efficacious treatment for COVID-19. While most patients recover on their own with basic measures at home, around 20% suffer a more aggressive disease requiring hospitalization, of which 5% necessitating intensive care unit (ICU) admission and potential invasive breathing support. The wide spectrum of COVID 19 also include a significant number of totally asymptomatic patients who are unknowingly spreading the disease. Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. This convalescent plasma could be beneficial, not only for severely ill and intubated patients, but also for those with moderate disease early in their disease course to prevent further disease progression and ICU admission.
- Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in
- intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT.
- hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19.
II. Study Population:
- Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older.
- Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness.
III. Study Duration: April 3, 2020 to December 31, 2022.
IV. Study Agent:
SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL at neutralization antibody titer >1:160. (Note this is a moving target as assays develop)). Product will be produced using Blood Bank of New Orleans and safety procedures and procured from patients who have been symptom free for 14 days and screen negative via NP swab or any other test that emerges in the meantime. Doors who have been symptoms free for more than 28 days are eligible to donate without the need of a NP swab. Any emerging FDA guidance will be followed.
- Conditions
- COVID-19
- Being tested
- Biological: COVID-19 convalescent plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: COVID-19 convalescent plasmaBiological
One unit of ABO compatible COVID-19 convalescent plasma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Nakhle Saba, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nakhle Saba, MD, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358211
- Sponsor's protocol ID
- 2020-595
- Status last verified
- Mar 2021
- First submitted
- 17 Apr 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
Publications
van Erp EA, Luytjes W, Ferwerda G, van Kasteren PB. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus Infection and Disease. Front Immunol. 2019 Mar 22;10:548. doi: 10.3389/fimmu.2019.00548. eCollection 2019.
PubMed 30967872Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.
PubMed 31826992Cheng 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 15616839Huang Z, Ning B, Yang HS, Youngquist BM, Niu A, Lyon CJ, Beddingfield BJ, Fears AC, Monk CH, Murrell AE, Bilton SJ, Linhuber JP, Norton EB, Dietrich ML, Yee J, Lai W, Scott JW, Yin XM, Rappaport J, Robinson JE, Saba NS, Roy CJ, Zwezdaryk KJ, Zhao Z, Hu TY. Sensitive tracking of circulating viral RNA through all stages of SARS-CoV-2 infection. J Clin Invest. 2021 Apr 1;131(7):e146031. doi: 10.1172/JCI146031.
PubMed 33561010
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19
- ClinicalTrials.gov ID
- NCT04358211
- Acronym / sponsor ID
- 2020-595
- Conditions
- COVID-19
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Nakhle Saba, MDUniversity, hospital or other
- First posted
- 24 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.
- Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in
- intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT.
- hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19.
II. Study Population:
- Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older.
- Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness.
III. Study Agent:
SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL at neutralization antibody titer >1:160.
Detailed description
There are currently no proven safe and efficacious treatment for COVID-19. While most patients recover on their own with basic measures at home, around 20% suffer a more aggressive disease requiring hospitalization, of which 5% necessitating intensive care unit (ICU) admission and potential invasive breathing support. The wide spectrum of COVID 19 also include a significant number of totally asymptomatic patients who are unknowingly spreading the disease. Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. This convalescent plasma could be beneficial, not only for severely ill and intubated patients, but also for those with moderate disease early in their disease course to prevent further disease progression and ICU admission.
- Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in
- intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT.
- hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19.
II. Study Population:
- Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older.
- Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness.
III. Study Duration: April 3, 2020 to December 31, 2022.
IV. Study Agent:
SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL at neutralization antibody titer >1:160. (Note this is a moving target as assays develop)). Product will be produced using Blood Bank of New Orleans and safety procedures and procured from patients who have been symptom free for 14 days and screen negative via NP swab or any other test that emerges in the meantime. Doors who have been symptoms free for more than 28 days are eligible to donate without the need of a NP swab. Any emerging FDA guidance will be followed.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Population 1: Associated Severe Pulmonary Complications
- 18 years or older.
- Hospitalized and intubated in the ICU with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements, or requirement for informed consent is WAIVED due to the inability to communicate with the patient and unable to identify legally authorized representative.
- Consents to storage of specimens for future testing, or consent waived.
- The requirements to waive a consent are delineated in 21 CFR 50.23 and will be followed.
Key exclusion criteria (7 listed)
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- Severe multi-organ failure with expected life expectancy < 24h as determined by the treating physician.
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- Receipt of pooled immunoglobulin in past 30 days.
- Contraindication to transfusion or history of prior reactions to transfusion blood products.
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 |
|---|---|---|
| Biological: COVID-19 convalescent plasmaOne unit of ABO compatible COVID-19 convalescent plasma | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Results publication: PubMed 30967872van Erp EA, Luytjes W, Ferwerda G, van Kasteren PB. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus Infection and Disease. Front Immunol. 2019 Mar 22;10:548. doi: 10.3389/fimmu.2019.00548. eCollection 2019.
- Results publication: PubMed 31826992Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.
- Results publication: PubMed 15616839Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
- Derived from this study: PubMed 33561010Huang Z, Ning B, Yang HS, Youngquist BM, Niu A, Lyon CJ, Beddingfield BJ, Fears AC, Monk CH, Murrell AE, Bilton SJ, Linhuber JP, Norton EB, Dietrich ML, Yee J, Lai W, Scott JW, Yin XM, Rappaport J, Robinson JE, Saba NS, Roy CJ, Zwezdaryk KJ, Zhao Z, Hu TY. Sensitive tracking of circulating viral RNA through all stages of SARS-CoV-2 infection. J Clin Invest. 2021 Apr 1;131(7):e146031. doi: 10.1172/JCI146031.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological: COVID-19 convalescent plasma in people with COVID-19, run by Nakhle Saba, MD at 1 site 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 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04358211, which also lists 4 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 8 Mar 2021.