RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Placebo for Post-COVID / Long-COVID

Q: Is NCT07021794 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07021794?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07021794?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This compared with a dummy treatment, randomly assigned, blinded, two-arm phase II study will test the safety and potential how well it works of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.

Official registry: https://clinicaltrials.gov/study/NCT07021794 · Nancy Klimas · enrollment listed as 100

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Placebo, or Sipavibart. The registry lists allocation as randomized. This compared with a dummy treatment, randomly assigned, blinded, two-arm phase II study will test the safety and potential how well it works of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.

They plan to enroll about 100 people at Fort Lauderdale. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Effectiveness of Treating Post-COVID-19 Conditions (Long COVID) With the SARS-CoV-2 Specific Monoclonal Antibody, Sipavibart

Interventions: Placebo, Sipavibart

Primary outcome (registry wording): Patient-Reported Outcomes Measurement Information System-29

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
An individual is eligible for inclusion if all of the following apply:
18 to 70 years old,
Inciting event: Acute COVID documented by testing (PCR or antigen testing in a clinical setting)
Onset of COVID symptoms occurring on or prior to August 31st, 2023; and persistence of symptomatic expression of Long COVID (defined #6 below) for more than 3 months after COVID diagnosis
Current symptomatic expression meets the case definition of ME/CFS
PROMIS 29 score at screening of moderate to severe (≥60)
Meets National Academy of Sciences (NAS) criteria for Long COVID with the following provisions:

Who the registry excludes

An individual is ineligible to participate if any of the following apply:
Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
Known severe anemia, defined as \< 8 g/dL
Known stroke that resulted in cognitive impairment within 3 months of enrollment
Allergy to any ingredient of the study drug (self-report)
Sipavibart is supplied as 150 mg/mL of active ingredient in 20 mM L-histidine/L-histidine hydrochloride, 220 mM L-arginine hydrochloride, and 0.04% (w/v) polysorbate 80, at pH 6.0
Hypersensitivity to other humanized mAbs

Public study contact (from the registry)

Nancy Klimas, MD

954-262-2286

nklimas@nova.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Nova Southeastern University — Fort Lauderdale, Florida (recruiting)

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FAQ about this NCT record

Is NCT07021794 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07021794?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07021794?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary