Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04446377
Other study ID # LAM-002A-CVD-CLN01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 15, 2020
Est. completion date April 19, 2021

Study information

Verified date August 2023
Source AI Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apilimod Dimesylate Capsule
LAM-002A is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, Size 0.
Other:
Placebo
Microcrystalline cellulose in Swedish orange, Size 0 capsules

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
AI Therapeutics, Inc. Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number and Percentage of Participants With Viral Load < Lower Limit of Quantification (LLOQ) Evaluated the difference in the number and percentage of participants with a SARS-CoV-2 viral load 4 Days
Primary Viral Load Change The primary efficacy outcome measure evaluated change in SARS-CoV-2 viral load at Day 4 from Day 1, of LAM-002A or placebo-treated participants. SARS-CoV-2 viral load was measured by a real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) test of nasopharyngeal samples. Analysis focused on log10 viral load on Day 4 compared to baseline viral load at Day 1 in participants with baseline viral load >100,000 copies/mL 4 Days
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAEs) The number and percentage of LAM 002A-treated participants who developed TEAEs compared to placebo 28 Days
Secondary Clinical Efficacy Number of Participants with Hospitalization or Death within 28 days 28 Days
Secondary Change in COVID-19 Clinical Status To evaluate change in COVID-19 clinical status, as defined by the ordinal scale, of participants treated with LAM-002A compared to placebo at Day 28, in participants who became hospitalized and continued LAM-002A/placebo treatment, based on the following scores:
Not in the hospital
Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula)
Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU)
Hospitalized, in the ICU, on invasive ventilation or Extracorporeal membrane oxygenation (ECMO)
Dead
28 Days
Secondary Oxygen Saturation Comparison of the number and percentage of participants with an oxygen saturation (O2 sat) =95% between LAM-002A versus placebo treatment groups. Baseline, Day 1, Day 4, Day 11, Day28
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04984408 - Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection. Phase 3
Terminated NCT04642638 - Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure Phase 2/Phase 3
Recruiting NCT04587323 - VEGF and sFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease
Completed NCT04682873 - A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19, Caused by the SARS-CoV-2 Virus Phase 3
Completed NCT04359212 - Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19
Completed NCT05603130 - Epidemiologic Register on Diabetes and COVID-19 in Tunisia
Completed NCT04830800 - A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC Phase 1/Phase 2
Completed NCT04757792 - Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU
Active, not recruiting NCT04417257 - Study of LAU-7b for the Treatment of COVID-19 Disease in Adults Phase 2/Phase 3
Recruiting NCT04522037 - Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients
Active, not recruiting NCT04969172 - A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection Phase 2
Completed NCT04366024 - A Novel Nomogram to Predict Severity of COVID-19
Completed NCT04347369 - A Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease
Completed NCT04787510 - COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection
Completed NCT05329220 - ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 Phase 3
Active, not recruiting NCT05077267 - ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects Phase 2
Completed NCT04472013 - Systematic Assessment of SARS-CoV-2 Neurotropic Capacity in Modestly and Critically Ill Patients, and Patients Who Died From COVID-19
Active, not recruiting NCT04371354 - Outcomes of Covid-19 Protective Measures in Endoscopy
Not yet recruiting NCT04779359 - Role of Lymphocyte Subsets and Laboratory Measurements in COVID-19 Disease