Using blood plasma to develop passive immunity to coronavirus in Ecuador

Investigating the use of convalescent plasma from patients who have recovered from COVID-19 in the management of Ecuadorian patients infected with SARS-CoV-2 with clinical deterioration: IMPACT

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85216856

Enrollment

200

Registered

2020-05-11

Start date

2020-05-10

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Respiratory COVID-19 (SARS-CoV-2 infection)

Interventions

Patients who meet the inclusion and exclusion criteria will be allocated into the study by simple randomization generated by random numbers with the SPSS software to one of the two treatment groups:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Clinical, molecular (using IgM/IgG or RT-PCR), or lung imaging diagnosis of COVID-19 3. Deterioration of previously normal lung function defined as SaO2 of <90% in 0.5 FiO2, and/or a higher requirement of O2 than in the previous 24h 4. A score of 5 to 7 on the early warning scale for COVID-19 patients or a SOFA score between 2 and 10 5. Informed consent provided by patients or their representatives

Exclusion criteria

Exclusion criteria: 1. Diagnosis and/or treatment for cancer 2. HIV infection 3. Currently receiving immunosuppressants for a condition other than SARS-CoV2 infection 4. Superimposed systemic infections 5. Liver or kidney failure 6. COPD, previous pulmonary fibrosis, and/or restrictive lung disease 7. Have received previous transfusions

Design outcomes

Primary

Measure	Time frame
Case fatality rate assessed through data collected from the follow-up instrument and medical record at 21 and 28 days	—

Secondary

Measure	Time frame
1. Demographic information, including age and sex will be collected using the specific instrument created to screen potential patients at baseline 2. Time of initiation of treatment in relation to the evolution of the disease assessed using the follow-up instrument which is completed daily from baseline to 21 days 3. Adverse reactions and interaction with other treatments, assessed through the medical record and follow-up instrument at the time of these events 4. Clinical recovery time assessed by the follow-up instrument which is completed daily from baseline to 21 days 5. Sequelae at discharge (liver, kidney functions, pulmonary, cardiac and neurological) assessed by the follow-up instrument at discharge 6. Hospitalization time, defined as time from admission until discharge from the hospital or death of the patient, assessed through clinician notes at the time of these events and the follow-up instrument	—

Measure

Time frame

1. Demographic information, including age and sex will be collected using the specific instrument created to screen potential patients at baseline 2. Time of initiation of treatment in relation to the evolution of the disease assessed using the follow-up instrument which is completed daily from baseline to 21 days 3. Adverse reactions and interaction with other treatments, assessed through the medical record and follow-up instrument at the time of these events 4. Clinical recovery time assessed by the follow-up instrument which is completed daily from baseline to 21 days 5. Sequelae at discharge (liver, kidney functions, pulmonary, cardiac and neurological) assessed by the follow-up instrument at discharge 6. Hospitalization time, defined as time from admission until discharge from the hospital or death of the patient, assessed through clinician notes at the time of these events and the follow-up instrument

—

Countries

Ecuador

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026