Covid19Phase 1/2NCT04573855
TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19
A Phase 1/2 study testing Anti-SARS-CoV-2 immunoglobulin in people with Covid19, run by D'Or Institute for Research and Education.
Trial summary
A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Anti-SARS-CoV-2 immunoglobulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 Mar 2021
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients diagnosed with COVID-19 by RT-PCR;
- Time between symptom onset and inclusion ≤ 10 days;
- Age ≥ 18 years and <75 years
- No indication of invasive ventilatory support at the time of randomization;
- Signature of the Informed Consent Form.
Who cannot join
- Pregnant or lactating women
- Severe comorbidity: Severe heart disease, severe COPD or O2-dependent COPD, terminal cancer.
- Any confirmed or suspected immunosuppressive or immunodeficiency state, including HIV (regardless of treatment, CD4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
- History of anaphylaxis or severe allergic reaction;
- Previous use of any heterologous serum;
- Participation in trials of prophylactic drugs or vaccines for COVID-19;
- Administration of immunoglobulins and / or any blood products in the previous three months.
About this study
Official title: TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY
A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.
- Conditions
- Covid19
- Being tested
- Anti-SARS-CoV-2 immunoglobulin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-SARS-CoV-2 immunoglobulinBiological
Treatment with Anti-SARS-CoV-2 immunoglobulin
| Study group | Role | What they receive |
|---|---|---|
| Anti-SARS-CoV-2 immunoglobulin | Experimental | Treatment with Anti-SARS-CoV-2 immunoglobulin Receives: Biological: Anti-SARS-CoV-2 immunoglobulin |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
Measured: 28 days
Clearence of viral RNA evaluated by RT-PCR
Measured: 72 h
Secondary outcomes (8)
Reduction of viral load evaluated by area under the curve of RT-PCR values
Viral load reduction evaluated by area under the curve of RT-PCR values
Measured: Day 0, Day 3, Day 7 and Day 14
Length of hospital stay
number of days between admission and discharge
Measured: For as long as the duration of the hospital stay
Orotracheal Intubation Rate
Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization
Measured: 28 days
Infusional reaction rate
number of patients who experienced adverse events after the immunoglobulin infusion
Measured: 28 days
Mortality rate
number of deceased patients
Measured: 28 days
Assessment of adverse events
Frequency of adverse events classified following CTCAE
Measured: 28 days
Evaluation of clinical status
Results of a 7-point ordinal severity scale
Measured: Day 0, Day 14, Day 21 and Day 28
Modulation of serum and cellular inflammatory marker
Exploratory analysis of the variation of inflammatory markers by ELISA/Luminex and flow cytometry, compared to baseline levels
Measured: Day 0, Day 3 and Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573855
- Sponsor's protocol ID
- PCL04/2020
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY
- ClinicalTrials.gov ID
- NCT04573855
- Acronym / sponsor ID
- PCL04/2020
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 5 Oct 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.
A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-SARS-CoV-2 immunoglobulin | Experimental | Biological: Anti-SARS-CoV-2 immunoglobulinTreatment with Anti-SARS-CoV-2 immunoglobulin |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatients diagnosed with COVID-19 by RT-PCR;
- Time between symptom onset and inclusion ≤ 10 days;
- Age ≥ 18 years and <75 years
- No indication of invasive ventilatory support at the time of randomization;
- Signature of the Informed Consent Form.
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Severe comorbidity: Severe heart disease, severe COPD or O2-dependent COPD, terminal cancer.
- Any confirmed or suspected immunosuppressive or immunodeficiency state, including HIV (regardless of treatment, CD4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
- History of anaphylaxis or severe allergic reaction;
- Previous use of any heterologous serum;
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 immunoglobulinTreatment with Anti-SARS-CoV-2 immunoglobulin | Biological | Anti-SARS-CoV-2 immunoglobulin |
Primary outcome
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
Time frame: 28 days
Clearence of viral RNA evaluated by RT-PCR
Time frame: 72 h
8 secondary outcomes
Reduction of viral load evaluated by area under the curve of RT-PCR values
Time frame: Day 0, Day 3, Day 7 and Day 14
Length of hospital stay
Time frame: For as long as the duration of the hospital stay
Orotracheal Intubation Rate
Time frame: 28 days
Infusional reaction rate
Time frame: 28 days
Mortality rate
Time frame: 28 days
Assessment of adverse events
Time frame: 28 days
Evaluation of clinical status
Time frame: Day 0, Day 14, Day 21 and Day 28
Modulation of serum and cellular inflammatory marker
Time frame: Day 0, Day 3 and Day 7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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 1/2 study testing Anti-SARS-CoV-2 immunoglobulin in people with Covid19, run by D'Or Institute for Research and Education.
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 5 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 5 Oct 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0. (time frame: 28 days). The study lists 2 primary outcomes in all. 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 5 Oct 2020.