BridgeMD
New treatment option for Long COVID
Official title A Study to Examine Anktiva for the Treatment of COVID-19.
ClinicalTrials.gov ID: NCT07123727
What this study is testing
What is Anktiva?
Anktiva is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for long covid.
Also referred to as N-803, Nogapendekin Alfa Inbakicept.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age ≥ 18 and \< 70 years.
- History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and/or a positive SARS-CoV-2...
- Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.
- At least 2 symptoms or at least 1 severe symptom as assessed by the study team (see list) that are new or worsened since the time of a SARS-CoV-2...
- Symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days...
You likely can't join if
- Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the...
- Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to plan to receive such treatment before...
- History of autoimmune disease including, but not limited, to celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.
- Active cardiovascular disease, defined as known prior:
- Myocardial infarction within 90 days of screening; OR
- Coronary artery bypass procedure within 90 days of screening; OR
See the full eligibility criteria
Who can join
- Age ≥ 18 and \< 70 years.
- History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and/or a positive SARS-CoV-2 antigen rapid diagnostic test (RDT). Those with only suspected but...
- Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.
- At least 2 symptoms or at least 1 severe symptom as assessed by the study team (see list) that are new or worsened since the time of a SARS-CoV-2 infection, not known to be attributable to another cause upon assessment...
- Symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening AND
- Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and/or everyday functioning AND
- At least 90 days have elapsed since the most recent suspected or confirmed SARS-CoV-2 infection and the time of screening. Note: suspected infections will be determined based upon assessment by the study Investigators.
- Not currently hospitalized.
- Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening.
- In otherwise stable health, as assessed by the Investigator within 28 days prior to screening, based on medical history, physical examination, laboratory findings, and vital signs.
- For male participants, a. Participants with partners that are WOCBP are strongly advised to inform their partners and must agree to use effective contraception from study entry (defined as INT1) through 7 months after...
- For female participants, a. A female participant who engages in sexual intercourse with male partners is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies: i. Is not a...
- Is a WOCBP and is using a contraceptive method from - 21 days from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration.
- A WOCBP must have a negative urine pregnancy test within 24 hours prior to all doses of study intervention. If a urine pregnancy test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test...
- Willingness and ability to comply with the study protocol. This includes reliable transportation and sufficient time to attend all visits.
- Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.
What rules you out
- Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the study.
- Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to plan to receive such treatment before exiting the study.
- History of autoimmune disease including, but not limited, to celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.
- Active cardiovascular disease, defined as known prior:
- Myocardial infarction within 90 days of screening; OR
- Coronary artery bypass procedure within 90 days of screening; OR
- Current heart failure with reduced ejection fraction (\<45%); OR
- Current pulmonary arterial hypertension.
- Known stroke within 3 months prior to planned INT1.
- Known active bacterial, fungal, viral, or other infection besides SARS-CoV-2 requiring treatment within the 14 days prior to INT1 and meeting criteria for systemic involvement upon review by the PI.
- Major surgery within 3 months prior to planned INT1 or planned major surgery during the first 75 days following planned INT1.
- History of unplanned hospitalization for \>24 hours within 28 days prior to Screening.
- Active or prior Hepatitis B (Hep B) infection (defined as Hep B core antibody (cAb) and/or Hep B surface antigen (sAg) positive. Note: Prior hepatitis B is exclusionary even in the absence of ongoing infection.
- Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA). Note: Those with cured Hep C (Ab positive or indeterminate but negative Hep C RNA) will remain eligible.
- Laboratory abnormalities including:
- ANC \< 1,500 per mm3
- Platelet count \<100,000 per mm3
- Hemoglobin \< 9 d/dL
- Baseline AST or ALT \> 1.5 × ULN
- CrCl \< 50 (estimated glomerular filtration rate)
- Known or suspected HIV infection.
- End stage kidney disease requiring dialysis.
- History of Type I or Type 2 Diabetes mellitus requiring systemic medication or insulin.
- Severe hepatic impairment (Child-Pugh Class C).
- Moderate or severe immunocompromise, includes the following: (a) receiving active treatment for solid tumor or hematologic malignancy, including use of systemic chemotherapy for treatment of cancer within the year prior...
- Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.
- Known prior diagnosis of dysautonomia, preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.
- Known allergy to any components used in the formulation of the intervention.
- History of anaphylaxis or similar significant allergic reaction to prescription or non-prescription drugs or food products. Similarly, the presence of severe atopic conditions as assessed by the PI represents a...
- Participation in a clinical trial with receipt of an investigational product within 28 days prior to planned INT1, except for exploratory PET imaging studies related to Long COVID.
- Current alcohol or illicit drug use as determined by the Investigator to preclude participation.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
The study team makes the final eligibility decision.
Where it's taking place
- El Segundo, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include El Segundo, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.