The purpose of this research study is to test if the combination of three drugs,valacyclovir, celecoxib, and Paxlovid will decrease the symptoms of Long COVID in adultscompared to a placebo (this does not contain the medications).
This is an off-label, randomized, double-blind, active placebo-controlled, two-arm
clinical trial of a combination of celecoxib, valacyclovir, and Paxlovid in adults with
Long COVID. This study aims to evaluate the safety and efficacy of the combination of
celecoxib, valacyclovir, and Paxlovid in adults with Long COVID (LC). Safety will be
primarily measured through blood and urine measures. Efficacy will be evaluated by
measuring patient-reported outcomes.
Drug: Valacyclovir
one to two 750mg capsules taken orally in the morning and evening
Drug: Celecoxib
200mg capsules taken orally in the morning and evening
Drug: Paxlovid
one (100mg ritonavir tablet and two 150mg nirmatrelvir tablets) taken orally in the
morning and evening
Drug: Placebo
matching placebo capsules and tablets taken orally in the morning and evening
Inclusion Criteria:
- 18-65 years of age at the time of study entry
- Diagnosed with Long COVID
- Individuals of child-bearing potential must have a negative serum pregnancy test at
screening and agree to on-site urine pregnancy testing at all subsequent study
visits
- A urine drug screen performed at the Screening Visit must be negative for drugs of
abuse such as methamphetamine, cocaine, phencyclidine (PCP), and non-disclosed
amphetamines and opioids/opiates.
- Those with mild to moderate depression should be clinically stable for three months,
without risk of suicidal ideation or behavior.
Exclusion Criteria:
- Breastfeeding, pregnant, or planning to become pregnant during the next six months.
- In the opinion of the Investigator, any clinically significant, uncontrolled, or
unstable medical or surgical condition that could affect the individual's ability to
participate in the study or potentially compromise their well-being while enrolled
in the study.
- In the opinion of the Investigator or based on results of the HADS, evidence of a
clinically significant psychiatric disorder, e.g., severe, unstable or poorly
controlled depression, anxiety or obsessive-compulsive disorder; moderate or severe
alcohol use disorder; substance use disorder other than mild cannabis use disorder;
or any history of bipolar disorder, schizophrenia, schizoaffective disorder or other
psychotic disorder.
- Currently meeting criteria for ME/CFS at the pre-screening or screening visit, or a
prior confirmed diagnosis of ME/CFS within the last 5 years. This may be determined
as part of the initial screening call or visit.
- Any anticipated need for surgery that in the opinion of the Principal Investigator
or Sub-I might confound results or interfere with the participant's ability to
comply with the protocol.
- Symptomatic and/or otherwise clinically significant cardiac disease
- Acute non-COVID systemic infection (e.g., HIV, hepatitis) or other active viral or
bacterial infection during the screening/washout period or at the Baseline visit.
- Currently receiving chronic systemic corticosteroids (>5 mg prednisone daily, or
equivalent)
- Routine treatment with warfarin, heparin, lithium, digoxin, amiodarone, isoniazid,
phenytoin, fluconazole, methotrexate, probenecid, or raloxifene. Participants on
these medications should not be screened.
- Uncontrolled sleep apnea.
- Use of chronic nucleoside analog antiviral suppression therapy within one month of
the Screening Visit or requiring on average more than one acute treatment course
every two months.
- Current use of celecoxib either alone or in combination with valacyclovir or
famciclovir
- In the opinion of the Investigator, evidence of current drug or alcohol abuse or
dependency, or history of abuse or dependence during the preceding 12 months.
- The participant has undergone a malabsorptive weight loss procedure (e.g., Roux-en-Y
or other bypass procedure).
- Severe IBS-C or colonic inertia as evidenced by seven or more days between bowel
movements.
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States
Investigator: David Putrino, PhD
David Putrino, PhD
212-241-7658
CoreResearch@mountsinai.org
David Putrino, PhD, Principal Investigator
Icahn School of Medicine at Mount Sinai