Health TrialsbyHealthPanel

SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)

ConditionPost-COVID / Long-COVID
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNancy Klimas

About this trial

This placebo-controlled, randomized, blinded, two-arm phase II study will test the safety and potential efficacy of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Self-report of current treated or untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or a history of CNS disorders that may affect cognitive function (i.e., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease), or substance abuse during the last two years, excluding cannabis products.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    A single dose of placebo (saline) indistinguishable from the active drug in appearance

  • Sipavibart

    Biological/Vaccine

    A single intramuscular dose of Sipavibart, 300 mg

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SipavibartExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient-Reported Outcomes Measurement Information System-29

Comprehensive Symptom Burden Index (CSBI) total scores will serve as a composite outcome measure derived from eight PROMIS domains to capture overall symptom burden. Scores will be calculated at baseline and Week 12. Efficacy will be determined by the proportion of participants classified as IMPROVED, defined as having a ≥4.5-point increase in CSBI from baseline, a threshold representing moderate and clinically meaningful improvement.

Time frame
12 weeks
2

Review of Treatment Related Adverse Events

Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.

Time frame
24 weeks

Secondary outcomes

1

Symptom-specific participant-reported outcome measures

Evaluate change in Comprehensive Symptom Burden Index (CSBI) score from baseline to Week 24 between Sipavibart and placebo groups.

Time frame
24 weeks
2

Change in Simple Reaction Time (Milliseconds)

Change in raw Simple Reaction Time, measured in milliseconds using the CNS Vital Signs computerized test battery, from baseline to Weeks 12 and 24.

Time frame
Baseline, 12 and 24 weeks
3

Self-reported fatigue using MFI

Change in Multidimensional Fatigue Inventory (MFI) total and subscale scores (General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, Reduced Motivation) from baseline to Weeks 12 and 24. Correlation of MFI scores with PROMIS Fatigue and DSQ-PEM subscales (convergent validity).

Time frame
12 and 24 weeks
4

Change in Heart Rate Post-6MWT

Change in Heart Rate post 6-minute walk distance (6MWT), in meters, from baseline to Weeks 12 and 24.Unit: Beats per minute (bpm)

Time frame
12 and 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nancy Klimas

Lead sponsor

Nova Southeastern University

Sponsor institution

Florida Department of Health

Collaborator

Source ClinicalTrials.gov
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