COVID-19Phase 2NCT05195749
A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care
A Phase 2 study testing 101-PGC-005 ('005) + SOC in people with COVID-19, run by 101 Therapeutics at 1 site in Israel.
Trial summary
In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan, China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely related to severe acute respiratory syndrome CoV (SARS-CoV) COVID-19, caused by the SARS-CoV-2 virus, leading to a major global… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- 101-PGC-005 ('005) + SOC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Jan 2022to 14 Feb 2023
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing and able to provide voluntary written informed consent and to follow the protocol specific requirements.
- Male or female patients over 18 years old.
- Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected within 7 days prior to enrollment) who are admitted or being admitted to the hospital for a primary diagnosis of COVID-19.
- In the case of female patients of child-bearing potential, a negative blood pregnancy test prior to beginning the therapy.
- Patients intended to be hospitalized to receive SOC including dexamethasone treatment for COVID-19.
Who cannot join
- Patients with evidence of other serious infections.
- Malignancy.
- Background disease which, in the opinion of the investigator prevents the patient from participating in the study such as:
- Presence of serious chronic infectious.
- A condition resulting in immunodeficiency.
- Participants with glucose levels upon admission ≥ 250 mg/dL
Show all 11Show fewer
- Acute psychosis
- Patients in a critical stage of COVID-19 disease that require mechanical ventilation.
- Pregnant and lactating women.
- Patients that are currently or have participated in other clinical studies with investigational drug, biological agent, or device within 1 month or within 5 half-lives (of the drug/biologic) prior to enrollment (whichever is longer).
- Patient currently receiving chemotherapy or immunosuppressive agents not including dexamethasone within 30 days before the screening.
Trial locations and contacts
1 site in 1 country.
About this study
In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan, China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely related to severe acute respiratory syndrome CoV (SARS-CoV) COVID-19, caused by the SARS-CoV-2 virus, leading to a major global public health threat. Many COVID-19 patients develop acute respiratory distress syndrome (ARDS) leading to death. The recent RECOVERY Trial demonstrated the success of dexamethasone in treating late-stage COVID-19 patients. However, use of dexamethasone increases mortality in the early stage of the disease, and dexamethasone is further limited because the therapeutic dose and duration is insufficient to safely and effectively treat most COVID-19 patients. As the majority of cells have glucocorticoid receptors to which dexamethasone binds, highly toxic doses would be needed to effectively treat COVID-19, which results in increased mortality as well as decreased natural immunity (via T-cell and other immune cell modulation). The investigational product 101-PGC-005 ('005) - a prodrug of dexamethasone that is targeted to only activated macrophages - will address the many safety and efficacy issues that limit dexamethasone. '005 can achieve much higher anti-inflammatory doses and avoid all undesirable immunosuppressive activities caused by standard dexamethasone administration, resulting in an even greater reduction in mortality among hospitalized patients and significantly reducing long term morbidity in patients who survive.
Read the detailed description
This prospective Phase IIa study will evaluate the safety of '005 for moderate to severe COVID-19 disease along with Standard of Care (SOC) treatment. The Nineteen (19) eligible patients will be enrolled to receive '005 + SOC, 10 additional patients will be enrolled to a control group receiving the SOC together with placebo.
At the first open-label stage, 3+3+3 design will be implemented. Three (3) patients will be enrolled to receive 10mg '005 together with SOC, three (3) patients will receive 20mg'005 together with SOC, and three (3) patients will receive 30mg '005 together with SOC if no safety concerns are identified the second stage will be initiated.
At the second double blind stage neither the participants nor the investigator will know which treatment participants are receiving until the clinical trial is over [20 patients will be enrolled and randomly allocated in a 1:1 ratio to the treatment (SOC +'005) or placebo group (SOC + placebo)]. The treatment dose will be chosen based on the first stage safety results.
NOTE: '005 will be administered daily for three (3) consecutive days starting from the day of enrollment.
Standard of Care will be administered as long as required, per Investigator's judgment, institutional practice, or local, national, or international guidelines for COVID-19 management.
A screening period of up to 7 days (Day-7 to Day-1) prior to enrollment will be followed by a study period of 28 days. Patients will be administered '005 daily from Day-1 to Day 3.
Total duration of study participation will not exceed 35 days.
- Conditions
- COVID-19
- Being tested
- 101-PGC-005 ('005) + SOC, Placebo + SOC
- Keywords
- Glucocorticoids, Corticosteroids, Dexamethasone, Infectious disease, Cytokine storm
- Medical subject headings
- COVID-19, Communicable Diseases, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
101-PGC-005 ('005) + SOCDrug
Three consecutive days of '005 administration
Placebo + SOCDrug
Three consecutive days of placebo administration
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Patients | Experimental | Moderate to severe COVID-19 patients receiving SOC and '005. Receives: Drug: 101-PGC-005 ('005) + SOC |
| Control | Placebo comparator | Moderate to severe COVID-19 patients receiving SOC and placebo. Receives: Drug: Placebo + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 2.
Evaluate the incidence of steroid-induced hyperglycemia Fasting Plasma Glucose (FPG).
Measured: At day 2
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 3.
Evaluate the incidence of steroid-induced hyperglycemia Fasting Plasma Glucose (FPG).
Measured: At day 3
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 4.
Evaluate the incidence of steroid-induced hyperglycemia Fasting Plasma Glucose (FPG).
Measured: At day 4
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 10.
Evaluate the incidence of steroid-induced hyperglycemia Fasting Plasma Glucose (FPG).
Measured: At day 10
Secondary outcomes (26)
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 2.
Evaluate the incidence of vital signs abnormality (i.e., pulse, oxygen saturation and blood pressure).
Measured: At day 2
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 3.
Evaluate the incidence of vital signs abnormality (i.e., pulse, oxygen saturation and blood pressure).
Measured: At day 3
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 4.
Evaluate the incidence of vital signs abnormality (i.e., pulse, oxygen saturation and blood pressure).
Measured: At day 4
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 10.
Evaluate the incidence of vital signs abnormality (i.e., pulse, oxygen saturation and blood pressure).
Measured: At day 10
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Evaluate the incidence of vital signs abnormality (i.e., pulse, oxygen saturation and blood pressure).
Measured: At day 28
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Evaluate the incidence of clinically significant changes in the blood CBC, and biochemistry.
Measured: At day 2
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Evaluate the incidence of clinically significant changes in the blood CBC, and biochemistry.
Measured: At day 3
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Evaluate the incidence of clinically significant changes in the blood CBC, and biochemistry.
Measured: At day 4
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Evaluate the incidence of clinically significant changes in the blood CBC, and biochemistry.
Measured: At day 10
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Evaluate the incidence of clinically significant changes in the blood CBC, and biochemistry.
Measured: At day 28
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Evaluate incidence of Adverse Events/Serious Adverse Events (AEs/SAEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) thru the study.
Measured: At 28 days
The 28 days discharge rate.
Comparison of 28 days discharge rate.
Measured: At 28 days
COVID-19 severity improvement by MOH COVID-19 severity scale while in hospital, and at days 10 and 28 if discharged.
COVID-19 severity improvement by MOH COVID-19 severity scale while in hospital, and at days 10 and 28 if discharged .
Measured: At 10 days
COVID-19 severity improvement by MOH COVID-19 severity scale while in hospital, and at days 10 and 28 if discharged.
COVID-19 severity improvement by MOH COVID-19 severity scale while in hospital, and at days 10 and 28 if discharged .
Measured: At 28 days
Reduction in inflammatory blood markers.
Reduction in CRP, or Ferritin levels at days 10 and 28.
Measured: At 10 days
Reduction in inflammatory blood markers.
Reduction in CRP, or Ferritin levels at days 10 and 28.
Measured: At 28 days
Improvement of COVID-19 symptoms.
Improvement in 1 or more COVID-19 symptoms severity from baseline (temperature, rate PaO2/FiO2, Mechanical ventilation or not mechanical ventilation) at days 10 or 28.
Measured: At day 28
Improvement of COVID-19 symptoms.
Improvement in 1 or more COVID-19 symptoms severity from baseline (temperature, rate PaO2/FiO2, Mechanical ventilation or not mechanical ventilation) at days 10 or 28.
Measured: At day 10
Time to Saturation ≥94% on Room Air
Time to Saturation ≥94% on Room Air at day 10
Measured: At day 10
Time to Saturation ≥94% on Room Air
Time to Saturation ≥94% on Room Air at day 28.
Measured: At day 28
Blood evaluation for '005 PK.
Evaluation of '005 kinetics in the blood at Day 1: at baseline 30 min, 1, 2, 4, 5, 6, 8 and 24hr post dose
Measured: At day 1: at baseline 30 min, 1, 2, 4, 5, 6, 8 and 24hr post dose
Blood evaluation for '005 PK.
Evaluation of '005 kinetics in the blood at Day 3: at baseline 30 min, 1, 2, 4, 5, 6, 8 and 24hr post dose
Measured: At day 3: at baseline 30 min, 1, 2, 4, 5, 6, 8 and 24hr post dose
Changes from baseline in pro-inflammatory cytokines and Lymphocyte subtypes.
Changes from baseline in pro-inflammatory cytokines and Lymphocyte subtypes at Day 4 and 10.
Measured: At day 4
Changes from baseline in pro-inflammatory cytokines and Lymphocyte subtypes.
Changes from baseline in pro-inflammatory cytokines and Lymphocyte subtypes at Day 4 and 10.
Measured: At day 10
Correlation with pro-inflammatory cytokines and change in COVID-19 symptoms
Correlation with pro-inflammatory cytokines and change in COVID-19 symptoms at Day 4.
Measured: At day 4
Correlation with pro-inflammatory cytokines and change in COVID-19 symptoms
Correlation with pro-inflammatory cytokines and change in COVID-19 symptoms at Day 10.
Measured: At day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start13 Jan 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 19 eligible patients will be enrolled to receive '005 + Standard of Care (SOC) and 10 patients will be enrolled to a control group receiving the SOC + placebo. The 1st open-label stage a 3+3+3 design will be implemented. 3 patients will receive 10mg '005 + SOC, 3 patients will receive 20mg '005 + SOC, and 3 patients will receive 30mg '005 + SOC. If no safety concerns are identified the 2nd stage will be initiated. All dose-escalation decisions will be based on previous cohort safety data, and doses will not be escalated unless 2 patients receiving the highest current dose have been observed for 24 hours post the 3rd dose. At the 2nd double blind stage neither the participants nor the investigator will know which treatment participants are receiving until the clinical trial is over. 20 patients will be enrolled and randomly allocated in a 1:1 ratio to the treatment (SOC + '005) or placebo group (SOC + placebo). The treatment dose will be chosen based on the 1st stage safety results.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- 101 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khetam Hussein, MD, Principal investigator, Rambam Healthcare Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195749
- Sponsor's protocol ID
- PGC-005-CP-101
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care
- ClinicalTrials.gov ID
- NCT05195749
- Acronym / sponsor ID
- PGC-005-CP-101
- Conditions
- COVID-19
- Keywords
- Glucocorticoids, Corticosteroids, Dexamethasone, Infectious disease, Cytokine storm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- 101 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 19 Jan 2022 (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.
In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan, China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely related to severe acute respiratory syndrome CoV (SARS-CoV) COVID-19, caused by the SARS-CoV-2 virus, leading to a major global public health threat. Many COVID-19 patients develop acute respiratory distress syndrome (ARDS) leading to death. The recent RECOVERY Trial demonstrated the success of dexamethasone in treating late-stage COVID-19 patients. However, use of dexamethasone increases mortality in the early stage of the disease, and dexamethasone is further limited because the therapeutic dose and duration is insufficient to safely and effectively treat most COVID-19 patients. As the majority of cells have glucocorticoid receptors to which dexamethasone binds, highly toxic doses would be needed to effectively treat COVID-19, which results in increased mortality as well as decreased natural immunity (via T-cell and other immune cell modulation). The investigational product 101-PGC-005 ('005) - a prodrug of dexamethasone that is targeted to only activated macrophages - will address the many safety and efficacy issues that limit dexamethasone. '005 can achieve much higher anti-inflammatory doses and avoid all undesirable immunosuppressive activities caused by standard dexamethasone administration, resulting in an even greater reduction in mortality among hospitalized patients and significantly reducing long term morbidity in patients who survive.
Detailed description
This prospective Phase IIa study will evaluate the safety of '005 for moderate to severe COVID-19 disease along with Standard of Care (SOC) treatment. The Nineteen (19) eligible patients will be enrolled to receive '005 + SOC, 10 additional patients will be enrolled to a control group receiving the SOC together with placebo.
At the first open-label stage, 3+3+3 design will be implemented. Three (3) patients will be enrolled to receive 10mg '005 together with SOC, three (3) patients will receive 20mg'005 together with SOC, and three (3) patients will receive 30mg '005 together with SOC if no safety concerns are identified the second stage will be initiated.
At the second double blind stage neither the participants nor the investigator will know which treatment participants are receiving until the clinical trial is over [20 patients will be enrolled and randomly allocated in a 1:1 ratio to the treatment (SOC +'005) or placebo group (SOC + placebo)]. The treatment dose will be chosen based on the first stage safety results.
NOTE: '005 will be administered daily for three (3) consecutive days starting from the day of enrollment.
Standard of Care will be administered as long as required, per Investigator's judgment, institutional practice, or local, national, or international guidelines for COVID-19 management.
A screening period of up to 7 days (Day-7 to Day-1) prior to enrollment will be followed by a study period of 28 days. Patients will be administered '005 daily from Day-1 to Day 3.
Total duration of study participation will not exceed 35 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 19 eligible patients will be enrolled to receive '005 + Standard of Care (SOC) and 10 patients will be enrolled to a control group receiving the SOC + placebo. The 1st open-label stage a 3+3+3 design will be implemented. 3 patients will receive 10mg '005 + SOC, 3 patients will receive 20mg '005 + SOC, and 3 patients will receive 30mg '005 + SOC. If no safety concerns are identified the 2nd stage will be initiated. All dose-escalation decisions will be based on previous cohort safety data, and doses will not be escalated unless 2 patients receiving the highest current dose have been observed for 24 hours post the 3rd dose. At the 2nd double blind stage neither the participants nor the investigator will know which treatment participants are receiving until the clinical trial is over. 20 patients will be enrolled and randomly allocated in a 1:1 ratio to the treatment (SOC + '005) or placebo group (SOC + placebo). The treatment dose will be chosen based on the 1st stage safety results.
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Patients | Experimental | Drug: 101-PGC-005 ('005) + SOCModerate to severe COVID-19 patients receiving SOC and '005. |
| Control | Placebo comparator | Drug: Placebo + SOCModerate to severe COVID-19 patients receiving SOC and placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients willing and able to provide voluntary written informed consent and to follow the protocol specific requirements.
- Male or female patients over 18 years old.
- Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected within 7 days prior to enrollment) who are admitted or being admitted to the hospital for a primary diagnosis of COVID-19.
- In the case of female patients of child-bearing potential, a negative blood pregnancy test prior to beginning the therapy.
- Patients intended to be hospitalized to receive SOC including dexamethasone treatment for COVID-19.
Key exclusion criteria (11 listed)
- Patients with evidence of other serious infections.
- Malignancy.
- Background disease which, in the opinion of the investigator prevents the patient from participating in the study such as:
- Patients in a critical stage of COVID-19 disease that require mechanical ventilation.
- Pregnant and lactating women.
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 |
|---|---|---|
| 101-PGC-005 ('005) + SOCThree consecutive days of '005 administration | Drug | COVID-19 Patients |
| Placebo + SOCThree consecutive days of placebo administration | Drug | Control |
Primary outcome
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 2.
Time frame: At day 2
Evaluate the incidence of steroid-induced hyperglycemia Fasting Plasma Glucose (FPG).
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 3.
Time frame: At day 3
Evaluate the incidence of steroid-induced hyperglycemia Fasting Plasma Glucose (FPG).
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 4.
Time frame: At day 4
Evaluate the incidence of steroid-induced hyperglycemia Fasting Plasma Glucose (FPG).
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 10.
Time frame: At day 10
Evaluate the incidence of steroid-induced hyperglycemia Fasting Plasma Glucose (FPG).
26 secondary outcomes
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 2.
Time frame: At day 2
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 3.
Time frame: At day 3
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 4.
Time frame: At day 4
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 10.
Time frame: At day 10
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Time frame: At day 28
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Time frame: At day 2
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Time frame: At day 3
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Time frame: At day 4
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Time frame: At day 10
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Time frame: At day 28
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment.
Time frame: At 28 days
The 28 days discharge rate.
Time frame: At 28 days
COVID-19 severity improvement by MOH COVID-19 severity scale while in hospital, and at days 10 and 28 if discharged.
Time frame: At 10 days
COVID-19 severity improvement by MOH COVID-19 severity scale while in hospital, and at days 10 and 28 if discharged.
Time frame: At 28 days
Reduction in inflammatory blood markers.
Time frame: At 10 days
Reduction in inflammatory blood markers.
Time frame: At 28 days
Improvement of COVID-19 symptoms.
Time frame: At day 28
Improvement of COVID-19 symptoms.
Time frame: At day 10
Time to Saturation ≥94% on Room Air
Time frame: At day 10
Time to Saturation ≥94% on Room Air
Time frame: At day 28
Blood evaluation for '005 PK.
Time frame: At day 1: at baseline 30 min, 1, 2, 4, 5, 6, 8 and 24hr post dose
Blood evaluation for '005 PK.
Time frame: At day 3: at baseline 30 min, 1, 2, 4, 5, 6, 8 and 24hr post dose
Changes from baseline in pro-inflammatory cytokines and Lymphocyte subtypes.
Time frame: At day 4
Changes from baseline in pro-inflammatory cytokines and Lymphocyte subtypes.
Time frame: At day 10
Correlation with pro-inflammatory cytokines and change in COVID-19 symptoms
Time frame: At day 4
Correlation with pro-inflammatory cytokines and change in COVID-19 symptoms
Time frame: At day 10
Results and safety
The study was stopped early (reason given: Low Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Khetam Hussein, MD principal investigator
Rambam Healthcare Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 101-PGC-005 ('005) + SOC in people with COVID-19, run by 101 Therapeutics at 1 site in Israel.
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 11 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: stopped early, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. 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 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?
The study was stopped early (reason given: Low Enrollment). 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?
To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 2. (time frame: At day 2). The study lists 4 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 24 Feb 2023.