Severe Acute Respiratory Syndrome Coronavirus 2NCT04360486
Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)
A study testing Anti-Sars-CoV-2 Convalescent Plasma in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by U.S. Army Medical Research and Development Command at 38 sites in 8 countries.
Trial summary
This treatment protocol is designed to provide convalescent plasma as a therapeutic option for patients diagnosed with and hospitalized for COVID-19 with symptoms ranging from mild to life-threatening. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Anti-Sars-CoV-2 Convalescent Plasma
- How many people
- Not given
- Where
- 38 sitesin 8 countries
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- A patient must meet the following criteria to be included in this protocol:
- DoD personnel covered by the Force Health Protection (FHP) program under the Department of Defense Instruction (DoDI) 6200.02 (active duty service members OCONUS and CONUS) and non-DoD personnel who may be treated for COVID-19 at Military Treatment Facilities (MTFs) under the authority of DoDI 6200.03, including Military Health System (MHS) beneficiaries, patients admitted to MTFs, and patients cared for under defense support for civilian authorities (e.g. hospital ships, field hospitals deployed for the COVID-19 response).
- Laboratory confirmed COVID-19 diagnosis
- Both PCR and antigen tests are considered to be diagnostic
- Serum antibody titer testing is not considered to be diagnostic, as patients who recently recovered from COVID-19 will still test positive)
- Hospitalized with symptoms ranging from mild to life-threatening
Show all 14Show fewer
- Informed consent provided by the patient or legally authorized representative (LAR), except in situations described in 21 CFR 50.23
- Understands and agrees to comply with planned protocol procedures
- In general, adults with SARS-CoV-2 infection can be grouped into the following severity of illness categories. However, the criteria for each category may overlap or vary across clinical guidelines and clinical trials, and a patient's clinical status may change over time.
- Asymptomatic or Presymptomatic Infection: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test or an antigen test) but who have no symptoms that are consistent with COVID-19.
- Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (eg, fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
- Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
- Severe Illness: Individuals who have SpO2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, respiratory frequency >30 breaths/min, or lung infiltrates >50%.
- Critical Illness: Individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction.
Who cannot join
- Patients who have a medical contraindication for plasma transfusion will be excluded from participation in this protocol. Any patient not meeting the inclusion criteria will not be eligible to receive this treatment. Patients will not be excluded because of receipt of another COVID-19 treatment(s) unless the principal investigator (treating physician) feels that the patient would be put at risk by receiving multiple therapies.
Trial locations and contacts
38 sites in 8 countries.
38 sites in 8 countries
United States26 sites
Keesler Medical Center
Biloxi, Mississippi, 39534
Eglin Air Force Base
Eglin Air Force Base, Florida, 32542
William Beaumont Army Medical Center
El Paso, Texas, 79920
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
Martin Army Community Hospital
Fort Benning, Georgia, 31905
Evans Army Community Hospital
Fort Carson, Colorado, 80913
Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Naval Hospital Jacksonville
Jacksonville, Florida, 32214
Madigan Army Medical Center
Lakewood, Washington, 98431
Nellis Air Force Base
Las Vegas, Nevada, 89191
Naval Medical Center Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, 28547
Naval Surface Force Atlantic
Norfolk, Virginia, 23511
USS Dwight D. Eisenhower
Norfolk, Virginia, 23511
USS Gerald R. Ford
Norfolk, Virginia, 23511
Naval Hospital Camp Pendleton
Oceanside, California, 92055
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Navy Medical Center San Diego
San Diego, California, 92134
USS Abraham Lincoln
San Diego, California, 92136
USS Carl Vinson
San Diego, California, 92136
USS Essex
San Diego, California, 92136
USS Makin Island
San Diego, California, 92136
USS Nimitz
San Diego, California, 92136
USS Theodore Roosevelt
San Diego, California, 92136
Wright Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433
Japan6 sites
Misawa Air Force Base
Aomori
Yokota Air Base
Fussa
US Naval Hospital Okinawa
Okinawa
Naval Hospital Yokosuka
Yokosuka
USS America
Yokosuka
USS Ronald Reagan
Yokosuka
Djibouti1 site
Djibouti Expeditionary Medical Facility
Djibouti
About this study
Official title: Expanded Access Protocol For The Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)
This treatment protocol is designed to provide convalescent plasma as a therapeutic option for patients diagnosed with and hospitalized for COVID-19 with symptoms ranging from mild to life-threatening.
Read the detailed description
This is an expanded access open-label, single-arm, multi-site protocol to provide convalescent plasma as a treatment for patients diagnosed with and hospitalized for COVID-19 with symptoms ranging from mild to life-threatening. Efficacy of this treatment will not be evaluated. A single site will initially be established. When additional patients needing therapy are identified at other health care facilities, Force Health Protection (FHP) will send a protocol package, and a site will be established and approved by the Headquarters USAMRDC Institutional Review Board (HQ IRB).
- Being tested
- Anti-Sars-CoV-2 Convalescent Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Sars-CoV-2 Convalescent PlasmaBiological
Fresh frozen plasma, Plasma Frozen for 24 hours (PF-24), or Liquid 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.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies 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
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360486
- Sponsor's protocol ID
- S-20-02
- Other IDs
- IND 19930
- Status last verified
- May 2023
- First submitted
- 20 Apr 2020
- Last updated
- 6 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol For The Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)
- ClinicalTrials.gov ID
- NCT04360486
- Acronym / sponsor ID
- S-20-02
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- 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.
This treatment protocol is designed to provide convalescent plasma as a therapeutic option for patients diagnosed with and hospitalized for COVID-19 with symptoms ranging from mild to life-threatening.
Detailed description
This is an expanded access open-label, single-arm, multi-site protocol to provide convalescent plasma as a treatment for patients diagnosed with and hospitalized for COVID-19 with symptoms ranging from mild to life-threatening. Efficacy of this treatment will not be evaluated. A single site will initially be established. When additional patients needing therapy are identified at other health care facilities, Force Health Protection (FHP) will send a protocol package, and a site will be established and approved by the Headquarters USAMRDC Institutional Review Board (HQ IRB).
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- DoD personnel covered by the Force Health Protection (FHP) program under the Department of Defense Instruction (DoDI) 6200.02 (active duty service members OCONUS and CONUS) and non-DoD personnel who may be treated for COVID-19 at Military Treatment Facilities (MTFs) under the authority of DoDI 6200.03, including Military Health System (MHS) beneficiaries, patients admitted to MTFs, and patients cared for under defense support for civilian authorities (e.g. hospital ships, field hospitals deployed for the COVID-19 response).
- Laboratory confirmed COVID-19 diagnosis
- Hospitalized with symptoms ranging from mild to life-threatening
- Informed consent provided by the patient or legally authorized representative (LAR), except in situations described in 21 CFR 50.23
- Understands and agrees to comply with planned protocol procedures
Key exclusion criteria (1 listed)
- Patients who have a medical contraindication for plasma transfusion will be excluded from participation in this protocol. Any patient not meeting the inclusion criteria will not be eligible to receive this treatment. Patients will not be excluded because of receipt of another COVID-19 treatment(s) unless the principal investigator (treating physician) feels that the patient would be put at risk by receiving multiple therapies.
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 PlasmaFresh frozen plasma, Plasma Frozen for 24 hours (PF-24), or Liquid 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 6 May 2023.
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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.
38 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Sars-CoV-2 Convalescent Plasma in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by U.S. Army Medical Research and Development Command at 38 sites in 8 countries.
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 14 inclusion and 1 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Japan, Afghanistan, Djibouti, Germany and 3 more countries. 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?
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 6 May 2023.