Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial

Official title:

Expanded Access Protocol For The Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04360486
• Other study ID #: S-20-02
• Secondary ID: IND 19930
• Status: No longer available

Study information

• Verified date: May 2023
• Source: U.S. Army Medical Research and Development Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical 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.

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).

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• 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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2

Intervention

Biological:
• Anti-Sars-CoV-2 Convalescent Plasma
Fresh frozen plasma, Plasma Frozen for 24 hours (PF-24), or Liquid plasma

Locations

Country	Name	City	State
Afghanistan	Craig Joint Theatre Hospital Bagram AFGH	Bagram
Djibouti	Djibouti Expeditionary Medical Facility	Djibouti
Germany	Landstuhl Regional Medical Center	Landstuhl
Guam	Naval Hospital Guam	Agaña
Iraq	Baghdad Diplomat Support Center Iraq	Baghdad
Japan	Misawa Air Force Base	Aomori
Japan	Yokota Air Base	Fussa
Japan	US Naval Hospital Okinawa	Okinawa
Japan	Naval Hospital Yokosuka	Yokosuka
Japan	USS America	Yokosuka
Japan	USS Ronald Reagan	Yokosuka
Kuwait	US Military Hospital Kuwait	Kuwait
United States	Keesler Medical Center	Biloxi	Mississippi
United States	Naval Medical Center Camp Lejeune	Camp Lejeune	North Carolina
United States	Eglin Air Force Base	Eglin Air Force Base	Florida
United States	William Beaumont Army Medical Center	El Paso	Texas
United States	Fort Belvoir Community Hospital	Fort Belvoir	Virginia
United States	Martin Army Community Hospital	Fort Benning	Georgia
United States	Evans Army Community Hospital	Fort Carson	Colorado
United States	Eisenhower Army Medical Center	Fort Gordon	Georgia
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Naval Hospital Jacksonville	Jacksonville	Florida
United States	Madigan Army Medical Center	Lakewood	Washington
United States	Nellis Air Force Base	Las Vegas	Nevada
United States	Naval Surface Force Atlantic	Norfolk	Virginia
United States	USS Dwight D. Eisenhower	Norfolk	Virginia
United States	USS Gerald R. Ford	Norfolk	Virginia
United States	Naval Hospital Camp Pendleton	Oceanside	California
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	Navy Medical Center San Diego	San Diego	California
United States	USS Abraham Lincoln	San Diego	California
United States	USS Carl Vinson	San Diego	California
United States	USS Essex	San Diego	California
United States	USS Makin Island	San Diego	California
United States	USS Nimitz	San Diego	California
United States	USS Theodore Roosevelt	San Diego	California
United States	Wright Patterson Medical Center	Wright-Patterson Air Force Base	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Development Command

Countries where clinical trial is conducted

United States,  Afghanistan,  Djibouti,  Germany,  Guam,  Iraq,  Japan,  Kuwait,