ACTIV-6: COVID-19 Study of Repurposed Medications

Purpose

The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person.

Condition

  • Covid19

Eligibility

Eligible Ages
Over 30 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Completed Informed Consent - Age ≥ 30 years old - Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening - Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell

Exclusion Criteria

  • Prior diagnosis of COVID-19 infection (> 10 days from screening) - Current or recent (within 10 days of screening) hospitalization - Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo - Known contraindication(s) to study drug including prohibited concomitant medications

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-Blind, Placebo-Controlled, Randomized Trial
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Masking Description
The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A - Ivermectin 400
Ivermectin - 7-mg tablets Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
  • Drug: Ivermectin
    Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
    Other names:
    • Ivermectin Tablets
Placebo Comparator
Arm A - Placebo
Placebo -7mg tablets Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
  • Other: Placebo
    Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
Experimental
Arm B - Fluvoxamine
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.
  • Drug: Fluvoxamine
    Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
    Other names:
    • Fluvoxamine Maleate Tablets
Placebo Comparator
Arm B- Placebo
Placebo will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.
  • Other: Placebo
    Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
Experimental
Arm C - Fluticasone
Fluticasone is a self-administered inhaled drug. Participants will self-administer 200 µg (1 blister) of fluticasone once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the study drug through the mouthpiece.
  • Drug: Fluticasone
    Fluticasone furoate is an inhaled powder drug product composed of fluticasone furoate. It is a synthetic trifluorinated corticosteroid that is insoluble in water. Fluticasone furoate is a white powder and will be provided in a two tone grey inhaler with a mouthpiece cover and separate foil blister strips. The inhaler will be packaged in a moisture-protective foil tray with a desiccant and a peelable lid.All packaging will be labeled to indicate that the product is for investigational use. Participants will self-administer 200 µg (1 blister) of fluticasone furoate once daily for 14 days.
    Other names:
    • Fluticasone Furoate
Placebo Comparator
Arm C - Placebo
Placebo is a self-administered inhaled drug. Participants will self-administer 200 µg (1 blister) of placebo once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the placebo through the mouthpiece.
  • Other: Placebo
    Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
Experimental
Arm D - Ivermectin 600
Ivermectin - 7-mg tablets Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 µg/kg.
  • Drug: Ivermectin
    Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
    Other names:
    • Ivermectin Tablets
Placebo Comparator
Arm D - Placebo
Placebo -7mg tablets Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 µg/kg.
  • Other: Placebo
    Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
Experimental
Arm E - Fluvoxamine 100
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
  • Drug: Fluvoxamine
    Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
    Other names:
    • Fluvoxamine Maleate Tablets
Placebo Comparator
Arm E - Placebo
Placebo will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
  • Other: Placebo
    Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
Experimental
Arm F - Montelukast
Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.
  • Drug: Montelukast
    Montelukast sodium is a white to off-white powder. The 10 mg montelukast tablets are beige, rounded square-shaped, biconvex, film-coated tablets, debossed "M10" on one side and plain on the other side. Each tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg montelukast. All packaging will be labeled to indicate that the product is for investigational use.
Placebo Comparator
Arm F - Placebo
Placebo will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.
  • Other: Placebo
    Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.

Recruiting Locations

Lamb Health, LLC
Gilbert, Arizona 85298
Contact:
Amron Harper
480-440-8666

First Care Medical Clinic
Mesa, Arizona 85203
Contact:
Mustafa Juma
602-544-2273
mjuma-pillai@cctdoctors.com

Trident Health Center
Peoria, Arizona 85382
Contact:
Madelyn Rosequist
888-635-0552

Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
Contact:
Julie Nguyen
949-824-3990
julie.nguyen@hoag.org

Assuta Family Medical Group APMC
North Hollywood, California 91606
Contact:
Jaya Nataraj
818-760-2800

Stanford
Palo Alto, California 94304
Contact:
Julia Donahue
jdonahu2@stanford.edu

Doctors Medical Group of Colorado Springs, P.C.
Colorado Springs, Colorado 80917
Contact:
Mailyn Marta
719-531-0409
robertspees@cctdoctors.com

Pine Ridge Family Medicine Inc.
Colorado Springs, Colorado 80924
Contact:
Vigil Vigil
719-550-5180
vecchiarellicrc@cctdoctors.com

Tabitha B. Fortt, M.D., LLC
Stamford, Connecticut 06905
Contact:
Anisa Fortt
203-674-0774
afortt-fortt@cctdoctors.com

George Washington University Hospital
Washington, District of Columbia 20037
Contact:
Andrew Meltzer
202-445-7044
ameltzer@mfa.gwu.edu

Arena Medical Group
Deerfield Beach, Florida 33441
Contact:
Sonaly DeAlmeida
954-715-3334

Lupus Foundation of Gainesville
Gainesville, Florida 32606
Contact:
Chariza Lopez
352-275-8171
cparsons-adhami@cctdoctors.com

University of Florida Health
Gainesville, Florida 32611
Contact:
Jamie Hensley
352-627-9107
jamiehensley@ufl.edu

University of Florida-JAX-ASCENT
Jacksonville, Florida 32209
Contact:
Jennifer Bowman
904-244-4691
jennifer.bowman@jax.ufl.edu

AMRON Vitality and Wellness Center, LLC
Jacksonville, Florida 32244
Contact:
Evelyn Rivera
yadibertin@gmail.com

Sunshine Walk In Clinic
Lake Mary, Florida 32746
Contact:
Beth Moritz
407-321-7111
bstmoritz-gupta@cctdoctors.com

Lakeland Regional Medical Center
Lakeland, Florida 33805
Contact:
Daniel Haight
863-687-1100
daniel.haight@mylrh.org

Jackson Memorial Hospital
Miami, Florida 33136
Contact:
Gisselle Jiminez
gisselle.jimenez@jhsmiami.org

University of Miami
Miami, Florida 33136
Contact:
Maria Almanzar
305-243-5157

Well Pharma Medical Research
Miami, Florida 33173
Contact:
Priscilla Huerta
305-665-4818
crcwellpharma@cctdoctors.com

Innovation Clinical Trials Inc.
Palmetto Bay, Florida 33157
Contact:
Lionel Reyes
305-554-6666
lreyes-unger@cctdoctors.com

Lice Source Services Plantation
Plantation, Florida 33313
Contact:
Arlen Quintero
954-791-0711

Premier Health
Saint Petersburg, Florida 33707
Contact:
Erica Burden
727-345-0160
erica@mypremierhealthcare.com

Tallahassee Memorial Hospital
Tallahassee, Florida 32308
Contact:
Marissa Ciesla
850-431-4947
marissa.ciesla@tmh.org

Tampa General Hospital
Tampa, Florida 33606
Contact:
Brenda Farlow
bfarlow@tgh.org

UF Health Precision Health Research
The Villages, Florida 32159
Contact:
Mitchell Roberts
352-247-2493
mroberts22@ufl.edu

Emory Healthcare
Atlanta, Georgia 30322
Contact:
Igho Ofotokun, MD
404-616-0659

Essential Medical Care, Inc.
College Park, Georgia 30349
Contact:
Marcella Rogers
305-665-4818
mrogers-james@cctdoctors.com

David Kavtaradze MD, Inc.
Cordele, Georgia 31015
Contact:
Cassandra Watson
229-271-4608
cwatson-kavtaradze@cctdoctors.com

Elite Family Practice
Douglasville, Georgia 30134
Contact:
Teri Hurst
678-715-2993
thurst-burruss@cctdoctors.com

Christ the King Health Care, P.C.
Loganville, Georgia 30052
Contact:
Adeolu Adebayo
770-554-8015
dadebayo-adebayo@cctdoctors.com

Miller Family Practice, LLC
Macon, Georgia 31201
Contact:
Hawa Wiley
478-745-7878
hwiley-miller@cctdoctors.com

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Dina Naquiallah
dina_naquiallah@rush.edu

Olivo Wellness Medical Center
Chicago, Illinois 60618
Contact:
Zainub Javed
773-423-6178
crcolivo@cctdoctors.com

NorthShore Medical Group
Evanston, Illinois 60201
Contact:
Nirav Shah, MD
219-201-8712

Advanced Medical Care, Ltd
Lake Zurich, Illinois 60047
Contact:
Jen Premas
847-438-4028
jpremas-bianchi@cctdoctors.com

Franciscan Health Michigan City
Michigan City, Indiana 46360
Contact:
Courtney Ramirez
219-809-9461
courtney.ramirez@franciscanalliance.org

Del Pilar Medical and Urgent Care
Mishawaka, Indiana 46545
Contact:
Amber Spangler
574-271-0268
arnolddelpilar@cctdoctors.com

University of Kansas - Wichita
Wichita, Kansas 67214
Contact:
Ashlie Cornejo
316-293-1833
acornejo@kumc.edu

A New Start II, LLC
Central City, Kentucky 42330
Contact:
Raina Vincent
270-754-3494
rainavincent78@gmail.com

University Medical Center- New Orleans
New Orleans, Louisiana 70112
Contact:
Wayne Swink
504-702-4852
swink@lcmchealth.org

Ochsner Clinic Foundation
New Orleans, Louisiana 70121
Contact:
Jake Hall
504-842-7413

Johns Hopkins Hospital
Baltimore, Maryland 21287-1900
Contact:
Lauren Stelmash
301-754-7556
lauren.stelmash@holycrosshealth.org

Jadestone Clinical Research, LLC
Rockville, Maryland 20855
Contact:
Matthew Wong
202-449-6869
matthew.wong@jadestonecr.com

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Katie Waite
617-414-6668
katherine.waite@bmc.org

Health Quality Primary Care
Lawrence, Massachusetts 01843
Contact:
Ivone Pagan
978-655-5349
ipagan-baez@cctdoctors.com

University of Massachusetts Medical School
Worcester, Massachusetts 01655
Contact:
Melissa Adams
508-856-5012
melissa.adams@umassmed.edu

Ananda Medical Clinic
Dearborn, Michigan 48124
Contact:
Greg Karawan
407-321-7111

GFC of Southeastern Michigan, PC
Detroit, Michigan 48202
Contact:
Nicole Koppinger
313-833-3090
nkoppinger-mehta@cctdoctors.com

Romancare Health Services
Detroit, Michigan 48206
Contact:
Jeffrey Harrison

Essentia Health
Duluth, Minnesota 55805
Contact:
Amber Lightfeather
amber.lightfeather@essentiahealth.org

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Manju Nayar
612-501-2079
nayar008@umn.edu

University of Missouri - Columbia
Columbia, Missouri 65212
Contact:
Michelle Seithel
573-884-4400
seithelm@health.missouri.edu

Comprehensive Pain Management and Endocrinology
Henderson, Nevada 89052
Contact:
Sebastian Munoz
munozs4@unlv.nevada.edu

Focus Clinical Research Solutions
Bayonne, New Jersey 07002
Contact:
Emad Ghaly
201-788-1372
eghaly-gabriel@cctdoctors.com

Raritan Bay Primary Care & Cardiology Associates
Matawan, New Jersey 07747
Contact:
Praksha Patel
732-709-8200
pap246@scarletmail.rutgers.edu

G&S Medical Associates, LLC
Paterson, New Jersey 07514
Contact:
Samah Ismail
hassaniencrc@cctdoctors.com

Mediversity Healthcare
Turnersville, New Jersey 08012
Contact:
Pravin Vasoya
856-740-9777
abdulghanicrc@cctdoctors.com

Geriatrics and Medical Associates
Clinton, New York 13323
Contact:
Angelina Roche
315-381-3576
aroche-brehaut@cctdoctors.com

Weill Cornell Medical College
New York, New York 10065
Contact:
Elizabeth Salsgiver
212-746-4089
els7021@med.cornell.edu

Spinal Pain and Medical Rehab, PC
Yonkers, New York 10701
Contact:
Sugata Shah
914-207-1161
sshah-shah@cctdoctors.com

Vaidya MD PLLC
Clayton, North Carolina 27520
Contact:
Cameron Gould
919-553-5711
tankcrc@cctdoctors.com

Maria Medical Center, PLLC
Dunn, North Carolina 28334
Contact:
Oksana Raymond
910-892-8892
oraymond-maria@cctdoctors.com

Duke Clinical Research Institute
Durham, North Carolina 27701
Contact:
Meaghan Beauchaine
833-385-1880
ACTIV-6_CC@dm.duke.edu

Duke University Medical Center
Durham, North Carolina 27710
Contact:
833-385-1880

Wake Forest Baptist Health
Winston-Salem, North Carolina 27151
Contact:
John Williamson, PharmD
336-713-3431

Diabetes and Endocrinology Assoc. of Stark County
Canton, Ohio 44718
Contact:
Brandi Kerr
brandik@go2endo.com

University of Cincinnati
Cincinnati, Ohio 45267
Contact:
Delia Miller
513-558-4774
mille5dp@ucmail.uc.edu

TriHealth, Inc
Montgomery, Ohio 45242
Contact:
Crystal Daffner
513-862-5119
crystal_daffner@trihealth.com

The Heart and Medical Center
Durant, Oklahoma 74701
Contact:
Drew Franklin
580-931-0500
dfranklin-khetpal@cctdoctors.com

Hugo Medical clinic
Hugo, Oklahoma 74743
Contact:
Llisa Hammons
580-326-6423
hammons-pardue@cctdoctors.com

Bucks County Clinical Research
Morrisville, Pennsylvania 19067
Contact:
Ginger Brounce
pennsbury@aol.com

Temple University Hospital
Philadelphia, Pennsylvania 19140
Contact:
Lillian Finlaw
lillian.finlaw@temple.edu

University of Pittsburgh
Pittsburgh, Pennsylvania 15213
Contact:
Emily Klawson
412-586-9796
ekk15@pitt.edu

Medical University of South Carolina
Charleston, South Carolina 29403
Contact:
Elizabeth Ann Szwast
843-792-4675
hinsone@musc.edu

Clinical Trials Center of Middle TN
Franklin, Tennessee 37067
Contact:
Alex Slandzicki, MD
615-205-8351

Rapha Family Wellness
Hendersonville, Tennessee 37075
Contact:
Laura Fisher
615-338-5750

Medical Specialists of Knoxville
Knoxville, Tennessee 37938
Contact:
Susie McGee
888-635-0552
susie.msok@comcast.net

Vanderbilt University Medical Center
Nashville, Tennessee 37203
Contact:
Carly Jones
615-322-0534
carly.jones@vumc.org

Express Family Clinic
Allen, Texas 75013
Contact:
De'Ambra Torress
972-672-4121
dtorress-parihar@cctdoctors.com

DHR Health Institute for Research
Edinburg, Texas 78539
Contact:
Luis Cantu
956-362-2393
lu.cantu@dhr-rgv.com

Texas Tech University Health Sciences Center
El Paso, Texas 79905
Contact:
Danielle Austin
danielle.austin@ttuhsc.edu

Brooke Army Medical Center
Fort Sam Houston, Texas 78234
Contact:
Genice Jacques
210-916-7796
genice.m.jacques.ctr@mail.mil

Texas Health Physicians Group
Fort Worth, Texas 76107
Contact:
Randall Richwine, MD
817-732-2878

Texas Health Physicians Group
Fort Worth, Texas 76107
Contact:
Penny Pazier
pennypazier@texashealth.org

Highlands Medical Associates, P.A.
Highlands, Texas 77562
Contact:
Mina Aziz
maziz-abdelsayed@cctdoctors.com

University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Virginia Umana
713-500-6733
virginia.e.umana@uth.tmc.edu

Family Practice Doctors P.A.
Humble, Texas 77338
Contact:
Ngozi Oguego
281-570-2606
noguego-oragwu@cctdoctors.com

Vytalus Medical Group
Humble, Texas 77338
Contact:
Amanda Sevier
asevier@vytalus.com

Texas Health Physicians Group
Irving, Texas 75039
Contact:
Lisa Carson
lisacarson@texashealth.org

University Diagnostics and Treatment Clinic
Pasadena, Texas 77504
Contact:
Mina Aziz
maziz-abdelsayed@cctdoctors.com

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Robin Tragus
210-203-3539
tragus@uthscsa.edu

Jeremy W. Szeto, D.O., P.A.
Sugar Land, Texas 77479
Contact:
Jessica Araica
jaraica-szeto@cctdoctors.com

University of Virginia
Charlottesville, Virginia 22903
Contact:
Heather Haughley
hmh8f@virginia.edu

More Details

NCT ID
NCT04885530
Status
Recruiting
Sponsor
Susanna Naggie, MD

Study Contact

Sybil Wilson
1-833-385-1880
sybil.wilson@duke.edu

Detailed Description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting. This proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization. This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2. Participants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo. The probability of placebo to treatment will remain the same regardless of eligibility decisions. Eligible participants will be randomized (1:1), in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. As additional study drugs are added, the randomization will be altered to leverage placebo data across arms. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized. All study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary.