Post-COVID / Long-COVIDPhase 2MonoclonalNCT07021794
SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)
A Phase 2 study testing Sipavibart in people with Post-COVID / Long-COVID, run by Nancy Klimas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-COVID / Long-COVID
- What is being tested?
- Sipavibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 58Show fewer
- Meets National Academy of Sciences (NAS) criteria for Long COVID with the following provisions:
- Allowance for normal illnesses of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and acceptable ranges at the time of screening and assessment. Specifically, blood pressures < 150 systolic and 90 diastolic mmHg are required.
- Allowance of stable comorbid conditions common in post viral illness, such as fibromyalgia, irritable bowel, interstitial cystitis, dysautonomia that have not required hospitalization in the two years prior to recruitment.
- Able to provide written consent to study. Agrees to participate in follow-up visits.
- Subject Exclusion Criteria
- 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.
- 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.
- 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.
- Current heavy alcohol or tobacco use (self-report). Alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day during the last month.
- Active chronic infections such as HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV), indicated by self-report, and abnormal liver function tests (>3x upper limit of normal) or evidence in the health record of chronic active hepatitis or human immunodeficiency virus (HIV).
- Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine > 2.0 mg/dL or eGFR < 44; or currently on renal dialysis)
- Liver disease (self-report or laboratory results: hepatic insufficiency (bilirubin >2.5mg/dL or transaminases > 3X the upper limits of normal)
- Uncontrolled diabetes, evidenced by combination of morning blood glucose and previous diagnosis of diabetes, AIC>7
- Diagnosed with congestive heart failure or significant arrythmia (ventricular tachycardia with a rapid rate at rest (> 100 bpm), persistent atrial fibrillation, or second- or third-degree heart block)
- Pre-existing sustained severe hypertension (BP >180/110 mmHg in the sitting position)
- Any of the following within 4 weeks of consent (Self-reported/medical record):
- an acute myocardial infarction or unstable angina
- uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema)
- acute pulmonary embolism
- suspected dissecting aneurysm
- severe hypoxemia at rest
- any acute or chronic disorder that may affect exercise performance, or
- if they are aggravated by exercise (e.g., infection, thyrotoxicosis, unable to cooperate)
- Diagnosed bleeding disorders or use of blood-thinning medications.
- Current or previous receipt of any COVID antiviral medication within 30 days prior to screening (self reported)
- Currently have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in the Ambiguities in case definition paper for CFS, as described in detail in [13] which clarifies exclusionary conditions. These exclusionary diagnoses that are not otherwise listed above comprise:
- Organ failure
- Chronic inflammatory diseases
- Major neurologic diseases that could cause fatigue or neurologic deficits
- Diseases requiring systemic treatment (i.e., transplantation, chemotherapy, radiation)
- Major endocrine diseases
- Untreated primary sleep disorders
- BMI > 40 kg/m2
- Temporary conditions discovered at screening, such as
- Temporary effects of medications
- Temporary sleep deprivation
- Untreated hypothyroidism, hypothyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limits
- Active infection (for COVID-19 infection and other infections, participants may be rescreened six weeks after resolution of infection)
- Known diagnosis of chronic Lyme disease with persistent symptoms, sequelae, or related therapy.
- Any marijuana illicit drug use within 30 days of informed consent
- Inability to discontinue symptomatic medications for the identified time periods
- Moderate or severe immunocompromised patients, such as those described in the NIH COVID-Treatment Guidelines
- Are scheduled for a surgery during the period of study participation, had minor surgery within three months prior to screening, or had major surgery within 6 months prior to screening
- Participating in any interventional (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another interventional clinical trial of an investigational therapy during the course of this study
- COVID Vaccination within 90 days prior to entry and for the duration of the study
- Pregnancy is excluded. Women of childbearing age will be given a pregnancy test.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nova Southeastern University
Fort Lauderdale, Florida, 33314
Alejandro Montealegre, APRN, 954-262-2286, am3841@nova.edu
Korrine Rodrigue, PhD, 802-779-8122, kr1686@nova.edu
About this study
Official title: Effectiveness of Treating Post-COVID-19 Conditions (Long COVID) With the SARS-CoV-2 Specific Monoclonal Antibody, Sipavibart
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.
Read the detailed description
Acute COVID-19 infection can present differently among infected patients, with the infection ranging in symptom presentation from asymptomatic and mild symptomatology to severe illness. Common symptoms tied to a COVID-19 infection include fever, chills, cough, respiratory ailments (shortness of breath or difficulty breathing), fatigue, muscle and/or joint pain, headache, loss of taste or smell, sore throat, congestion, and/or gastrointestinal (GI) disturbances (nausea, vomiting, and/or diarrhea). In some patients, these symptoms are short-lived and span the length of the acute infection, while in many patients the symptoms can linger for an extended period. Early indications point to inflammation playing a key role in acute COVID-19 illness and severity, and may play a role in prolonged Long COVID(LC) symptom intolerance and long-term sequelae. Researchers have demonstrated the involvement of persistent inflammation, poor antiviral responses, and evidence of chronic viral reactivation.
More recently, studies have demonstrated that mAb targeting the spike (S) protein of the SARS-CoV-2 may not only be effective in treating acute COVID-19 infection, especially variants prior to Omicron (alpha, beta, and delta), but also may play a role in addressing Long COVID. This implies that mAb infusions likely target SARS-CoV-2, decreasing activity, and potentially addressing disease pathogenesis tied to its activation, shutting down negative implications of inflammation tied to viral activation. This study will employ a two-arm randomized design to evaluate the efficacy of the drug Sipavibart in individuals experiencing LC symptoms. Participants will undergo six months of follow up after receiving either one dose of Sipavibart or one dose of placebo. After completion of the 6-month follow up, an open-label extension phase will be added at month 6 (week 24), where subjects who continue to experience symptoms of long COVID (regardless of the blinded treatment assignment) could be eligible to receive one dose of Sipavibart in an open-label fashion.
- Conditions
- Post-COVID / Long-COVID
- Being tested
- Placebo, Sipavibart
- Keywords
- LongCOVID, Monoclonal antibody (mAb) therapy, Post-viral conditions
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
A single dose of placebo (saline) indistinguishable from the active drug in appearance
SipavibartBiological
A single intramuscular dose of Sipavibart, 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Sipavibart | Experimental | Participants receive a single intramuscular dose of Sipavibart, 300 mg intramuscular and are then followed for a duration of six months. Receives: Drug: Placebo |
| Placebo | Placebo comparator | Participants receive single dose of placebo (saline) indistinguishable from the active drug in appearance, and are then followed for a duration of six months. Receives: Biological: Sipavibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 24 weeks
Secondary outcomes (24)
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.
Measured: 24 weeks
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.
Measured: Baseline, 12 and 24 weeks
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).
Measured: 12 and 24 weeks
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)
Measured: 12 and 24 weeks
Processing Speed
Change in Processing Speed score (Standard score or percentile) from baseline to Weeks 12 and 24 as measured by CNS Vital Signs.
Measured: 12 and 24 weeks
Attention
Change in Attention (Standard Score) from baseline to Weeks 12 and 24 as measured by CNS Vital Signs.
Measured: Baseline, 12 and 24 weeks
Systolic Blood Pressure Response During NASA Lean Test
Change in systolic blood pressure (mmHg) from baseline to 10 minutes upright during the NASA Lean Test
Measured: Baseline, 12 and 24 Weeks
Diastolic Blood Pressure Response During NASA Lean Test
Change in diastolic blood pressure (mmHg) from baseline to 10 minutes upright during the NASA Lean Test
Measured: Baseline, 12 and 24 Weeks
Symptom Score During NASA Lean Test
Change in self-reported orthostatic intolerance symptom score, measured using a 0-10 numeric scale, during the NASA 10-minute Lean Test
Measured: Baseline, 12 and 24 weeks
Within-participant change in PROMIS Fatigue scores from baseline to Week 24
PROMIS Fatigue domain score measured at baseline, Week 12, and Week 24 to assess change over time.
Measured: Baseline, 12 weeks, 24 weeks
Within-participant change in PROMIS Pain Interference scores
PROMIS Pain Interference domain score measured at baseline, Week 12, and Week 24 to assess change over time.
Measured: Baseline, 12 weeks, 24 weeks
Within-participant change in PROMIS Physical Function scores
PROMIS Physical Function domain score measured at baseline, Week 12, and Week 24 to assess change over time.
Measured: Baseline, 12 weeks, 24 weeks
Change in PROMIS Cognitive Function 8a T-score
Evaluates cognitive function using PROMIS Cognitive Function 8a at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster (Cognitive Dysfunction group).
Measured: Baseline, 12 Week, 24 week
Change in Orthostatic Hypotension Questionnaire (OHQ) composite score
Evaluates autonomic dysfunction using the OHQ at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster (Autonomic Dysfunction group).
Measured: Baseline, 12 weeks, 24 weeks
Change in DePaul Symptom Questionnaire-Post-Exertional Malaise (DSQ-PEM)
Evaluates post-exertional malaise and exercise intolerance using the DSQ-PEM T score at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster .
Measured: Baseline, 12 weeks, 24 weeks
Change in DePaul Symptom Questionnaire (DSQ) score
Assesses symptom burden using the DSQ at baseline, Week 12, and Week 24.
Measured: Baseline, 12 weeks, 24 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) global score
Assesses sleep quality using the PSQI at baseline, Week 12, and Week 24. Scores (0-21)
Measured: Baseline, 12 weeks, 24 weeks
Change in Brief Pain Inventory (BPI) severity score
Assesses pain severity using the BPI at baseline, Week 12, and Week 24. Scores (1-10).
Measured: Baseline, 12 weeks, 24 weeks
Change in Modified Medical Research Council (mMRC) Dyspnea Scale score
Assesses dyspnea using the mMRC scale at baseline, Week 12, and Week 24. Score range 0-4
Measured: Baseline, 12 weeks, 24 weeks
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Assesses anxiety symptoms using the GAD-7 at baseline, Week 12, and Week 24. Score range 0-21
Measured: Baseline, 12 weeks, 24 weeks
Change in Patient Health Questionnaire-8 (PHQ-8) score
Assesses depressive symptoms using the PHQ-8 at baseline, Week 12, and Week 24. Score range 0-24
Measured: Baseline, 12 weeks, 24 weeks
Change in Brief Illness Perception Questionnaire (B-IPQ) total score
Assesses illness perception using the B-IPQ at baseline, Week 12, and Week 24. Score range 0-80
Measured: Baseline, 12 weeks, 24 weeks
Change in Functional Capacity Scale (FUNCAP) score
Assesses functional impairment using the FUNCAP scale at baseline, Week 12, and Week 24. Score range 0-100
Measured: Baseline, 12 weeks, 24 weeks.
Change in Composite Symptom Burden Index (CSBI) score
The CSBI is a derived score summarizing symptom burden across multiple validated domains (e.g., fatigue, pain, sleep, mood, cognitive function). Domain scores are standardized and averaged to produce a single CSBI value per participant. Paired differences from baseline to Week 12 and Week 24 will be analyzed to assess intra-individual changes and overall cohort-level trends.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start28 Jul 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID / Long-COVIDStudies 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
- 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 100 patients with Long COVID.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nancy Klimas
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor-investigator, Nancy Klimas, Nova Southeastern University
- Investigators
- Nancy Klimas, MD, Principal investigator, Nova Southeastern UniversityKorrine Rodrigue, PhD, Study director, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021794
- Sponsor's protocol ID
- LongCovid Monoclonal Antibody
- Acronym
- Monoclonal
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Treating Post-COVID-19 Conditions (Long COVID) With the SARS-CoV-2 Specific Monoclonal Antibody, Sipavibart
- ClinicalTrials.gov ID
- NCT07021794
- Acronym / sponsor ID
- Monoclonal / LongCovid Monoclonal Antibody
- Conditions
- Post-COVID / Long-COVID
- Keywords
- LongCOVID, Monoclonal antibody (mAb) therapy, Post-viral conditions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nancy KlimasUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Jun 2025 (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.
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.
Detailed description
Acute COVID-19 infection can present differently among infected patients, with the infection ranging in symptom presentation from asymptomatic and mild symptomatology to severe illness. Common symptoms tied to a COVID-19 infection include fever, chills, cough, respiratory ailments (shortness of breath or difficulty breathing), fatigue, muscle and/or joint pain, headache, loss of taste or smell, sore throat, congestion, and/or gastrointestinal (GI) disturbances (nausea, vomiting, and/or diarrhea). In some patients, these symptoms are short-lived and span the length of the acute infection, while in many patients the symptoms can linger for an extended period. Early indications point to inflammation playing a key role in acute COVID-19 illness and severity, and may play a role in prolonged Long COVID(LC) symptom intolerance and long-term sequelae. Researchers have demonstrated the involvement of persistent inflammation, poor antiviral responses, and evidence of chronic viral reactivation.
More recently, studies have demonstrated that mAb targeting the spike (S) protein of the SARS-CoV-2 may not only be effective in treating acute COVID-19 infection, especially variants prior to Omicron (alpha, beta, and delta), but also may play a role in addressing Long COVID. This implies that mAb infusions likely target SARS-CoV-2, decreasing activity, and potentially addressing disease pathogenesis tied to its activation, shutting down negative implications of inflammation tied to viral activation. This study will employ a two-arm randomized design to evaluate the efficacy of the drug Sipavibart in individuals experiencing LC symptoms. Participants will undergo six months of follow up after receiving either one dose of Sipavibart or one dose of placebo. After completion of the 6-month follow up, an open-label extension phase will be added at month 6 (week 24), where subjects who continue to experience symptoms of long COVID (regardless of the blinded treatment assignment) could be eligible to receive one dose of Sipavibart in an open-label fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 100 patients with Long COVID.
| Arm | Type | Receives |
|---|---|---|
| Sipavibart | Experimental | Drug: PlaceboParticipants receive a single intramuscular dose of Sipavibart, 300 mg intramuscular and are then followed for a duration of six months. |
| Placebo | Placebo comparator | Biological: SipavibartParticipants receive single dose of placebo (saline) indistinguishable from the active drug in appearance, and are then followed for a duration of six months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (58 listed)
- 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).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PlaceboA single dose of placebo (saline) indistinguishable from the active drug in appearance | Drug | Sipavibart |
| SipavibartA single intramuscular dose of Sipavibart, 300 mg | Biological | Placebo |
Primary outcome
Patient-Reported Outcomes Measurement Information System-29
Time frame: 12 weeks
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.
Review of Treatment Related Adverse Events
Time frame: 24 weeks
Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.
24 secondary outcomes
Symptom-specific participant-reported outcome measures
Time frame: 24 weeks
Change in Simple Reaction Time (Milliseconds)
Time frame: Baseline, 12 and 24 weeks
Self-reported fatigue using MFI
Time frame: 12 and 24 weeks
Change in Heart Rate Post-6MWT
Time frame: 12 and 24 weeks
Processing Speed
Time frame: 12 and 24 weeks
Attention
Time frame: Baseline, 12 and 24 weeks
Systolic Blood Pressure Response During NASA Lean Test
Time frame: Baseline, 12 and 24 Weeks
Diastolic Blood Pressure Response During NASA Lean Test
Time frame: Baseline, 12 and 24 Weeks
Symptom Score During NASA Lean Test
Time frame: Baseline, 12 and 24 weeks
Within-participant change in PROMIS Fatigue scores from baseline to Week 24
Time frame: Baseline, 12 weeks, 24 weeks
Within-participant change in PROMIS Pain Interference scores
Time frame: Baseline, 12 weeks, 24 weeks
Within-participant change in PROMIS Physical Function scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in PROMIS Cognitive Function 8a T-score
Time frame: Baseline, 12 Week, 24 week
Change in Orthostatic Hypotension Questionnaire (OHQ) composite score
Time frame: Baseline, 12 weeks, 24 weeks
Change in DePaul Symptom Questionnaire-Post-Exertional Malaise (DSQ-PEM)
Time frame: Baseline, 12 weeks, 24 weeks
Change in DePaul Symptom Questionnaire (DSQ) score
Time frame: Baseline, 12 weeks, 24 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: Baseline, 12 weeks, 24 weeks
Change in Brief Pain Inventory (BPI) severity score
Time frame: Baseline, 12 weeks, 24 weeks
Change in Modified Medical Research Council (mMRC) Dyspnea Scale score
Time frame: Baseline, 12 weeks, 24 weeks
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline, 12 weeks, 24 weeks
Change in Patient Health Questionnaire-8 (PHQ-8) score
Time frame: Baseline, 12 weeks, 24 weeks
Change in Brief Illness Perception Questionnaire (B-IPQ) total score
Time frame: Baseline, 12 weeks, 24 weeks
Change in Functional Capacity Scale (FUNCAP) score
Time frame: Baseline, 12 weeks, 24 weeks.
Change in Composite Symptom Burden Index (CSBI) score
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Nancy Klimas, MD principal investigator
Nova Southeastern University
Korrine Rodrigue, PhD study director
Nova Southeastern University
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 Sipavibart in people with Post-COVID / Long-COVID, run by Nancy Klimas at 1 site in United States.
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 58 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Klimas, MD (954-262-2286, nklimas@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System-29 (time frame: 12 weeks). The study lists 2 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 29 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.