Pneumonia, InterstitialPhase 1NCT04333251
Study Testing Convalescent Plasma vs Best Supportive Care
A Phase 1 study testing high-titer anti-Sars-CoV-2 plasma and oxygen therapy in people with Pneumonia, Interstitial, run by Baylor Research Institute.
Trial summary
Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Interstitial
- What is being tested?
- high-titer anti-Sars-CoV-2 plasma and oxygen therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2020to 7 Sep 2021
- Phase
- Phase 1
- 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
- 18 years or older
- must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing
- females of child-bearing potential must have a negative serum pregnancy test
- subject and/or LAR willing to provide informed consent
- patient agrees to storage of specimens for future testing
- 18 years or older
Show all 9Show fewer
- must have been hospitalized w/COVID-19 respiratory symptoms within 3 to 7 days from the beginning of illness
- subject and/or LAR willing to provide informed consent
- patient agrees to storage of specimens for future testing
Who cannot join
- 18 years or older
- receipt of pooled immunoglobulin in past 30 days
- contraindication to transfusion or history of prior reactions to transfusion blood products
- females who are identified as donors must not be pregnant
About this study
Official title: Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19
Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.
Read the detailed description
Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.
- Conditions
- Pneumonia, Interstitial
- Being tested
- high-titer anti-Sars-CoV-2 plasma, oxygen therapy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-titer anti-Sars-CoV-2 plasmaBiological
Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer >1:64 vs best supportive care
oxygen therapyOther
oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| convalescent plasma | Experimental | This arm will receive convalescent plasma Receives: Biological: high-titer anti-Sars-CoV-2 plasma |
| best supportive care | Placebo comparator | Oxygen therapy Receives: Other: oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in oxygen and ventilation support
reduction in oxygen and ventilation support
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start17 Apr 2020
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Why it stopped: Funding was not obtained and study was not activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, InterstitialStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333251
- Sponsor's protocol ID
- 020-123
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2020
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19
- ClinicalTrials.gov ID
- NCT04333251
- Acronym / sponsor ID
- 020-123
- Conditions
- Pneumonia, Interstitial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not obtained and study was not activated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 3 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.
Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.
Detailed description
Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| convalescent plasma | Experimental | Biological: high-titer anti-Sars-CoV-2 plasmaThis arm will receive convalescent plasma |
| best supportive care | Placebo comparator | Other: oxygen therapyOxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing
- females of child-bearing potential must have a negative serum pregnancy test
- subject and/or LAR willing to provide informed consent
- patient agrees to storage of specimens for future testing
Key exclusion criteria (4 listed)
- 18 years or older
- receipt of pooled immunoglobulin in past 30 days
- contraindication to transfusion or history of prior reactions to transfusion blood products
- females who are identified as donors must not be pregnant
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 |
|---|---|---|
| high-titer anti-Sars-CoV-2 plasmaRecipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer >1:64 vs best supportive care | Biological | convalescent plasma |
| oxygen therapyoxygen therapy | Other | best supportive care |
Primary outcome
reduction in oxygen and ventilation support
Time frame: through study completion, an average of 4 weeks
reduction in oxygen and ventilation support
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing high-titer anti-Sars-CoV-2 plasma and oxygen therapy in people with Pneumonia, Interstitial, run by Baylor Research Institute.
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 9 inclusion and 4 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: withdrawn, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 withdrawn before enrolling participants, so there are no results.
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?
reduction in oxygen and ventilation support (time frame: through study completion, an average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.