Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2021-02-19
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tafenoquine
Tafenoquine two 100 mg oral tablets 1x/day on Days 1,2,3 and 10
Tafenoquine Oral Tablet
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
Placebo
Placebo two tablets 1x/day on Days 1,2,3 and 10
Placebo
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
Interventions
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Tafenoquine Oral Tablet
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
Placebo
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Laboratory confirmed infection with COVID-19 virus by an FDA-authorized SARS-Cov-2 RT-PCR;
* Able and willing to give written informed consent.
* Willing to keep an electronic diary from Study Day 1 to Study Day 13 (± 1 day) and Study Day 15 (± 1 day) to Study Day 28 (± 1 day)
* Willing to have daily phone or videoconferences with study team personnel from Study Day 1 to Day 13 (± 1 day) and Day 28
* At least one of the following clinical symptoms of COVID-19 infection within the 4 days prior to and inclusive of the day of screening:
1. Respiratory rate ≥ 24/min
2. New cough or shortness of breath that has presented within the last 4 days
3. Fever - temperature 37.7°C \[oral or skin surface\]
* Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of the study.
* Able to take ARAKODA or KODATEF according to Prescribing Information
* Have been symptomatic no longer than 7 days when the first dose of study medication is administered.
* If female, agree to use an acceptable method of birth control from the time of consent through 56 days after the last dose of study drug.
Exclusion Criteria
1. G6PD deficiency
2. Breastfeeding
3. Psychotic disorder or current psychotic symptoms
4. Known hypersensitivity reaction to TQ
* Evidence of severe or critical illness, defined by at least one of the following:
1. Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2 ≤93% on room air
2. Respiratory failure defined based on resource utilization requiring at least one of the following:
i. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. Shock (defined by systolic blood pressure \< 90 mmHg, or diastolic blood pressure \<60 mmHg or requiring vasopressors) iii. Multi-organ dysfunction/failure
* Any other clinically significant acute illness unrelated to COVID-19 within seven days prior to first study drug administration
* Receipt of any experimental treatment for COVID-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation
* Any excluded concomitant medication as described in the ARAKODA package insert \[Section 16.1\]. Receipt of a COVID-19 vaccine is not exclusionary.
* Any COVID-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment
* Positive pregnancy test
* Have been symptomatic for more than seven days when the first dose would be administered
18 Years
ALL
No
Sponsors
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60 Degrees Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Akila Chandrasekar, MD
Role: STUDY_DIRECTOR
Peachtree BioResearch Solutions Inc.
Locations
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Deluxe Health Center LLC
Miami, Florida, United States
Hope Clinical Trials
Miami, Florida, United States
F&T Medical Research, Inc.
Miami, Florida, United States
Kendall South Medical Center, Inc.
Miami, Florida, United States
Skyline Medical Center
Elkhorn, Nebraska, United States
Burke Primary Care
Morgantown, North Carolina, United States
AFC Urgent Care
Easley, South Carolina, United States
Centex Studies
Brownsville, Texas, United States
Care United
Forney, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Countries
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References
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Geleris J, Sun Y, Platt J, Zucker J, Baldwin M, Hripcsak G, Labella A, Manson DK, Kubin C, Barr RG, Sobieszczyk ME, Schluger NW. Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med. 2020 Jun 18;382(25):2411-2418. doi: 10.1056/NEJMoa2012410. Epub 2020 May 7.
Xiao F, Tang M, Zheng X, Liu Y, Li X, Shan H. Evidence for Gastrointestinal Infection of SARS-CoV-2. Gastroenterology. 2020 May;158(6):1831-1833.e3. doi: 10.1053/j.gastro.2020.02.055. Epub 2020 Mar 3. No abstract available.
Center for Disease Control. CDC Covid-19 data tracker. https://www.cdc.gov/covid-data-tracker/index.html#cases. Accessed March 7, 2020.
Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8.
Brueckner RP, Lasseter KC, Lin ET, Schuster BG. First-time-in-humans safety and pharmacokinetics of WR 238605, a new antimalarial. Am J Trop Med Hyg. 1998 May;58(5):645-9. doi: 10.4269/ajtmh.1998.58.645.
Crisafulli E, Clini EM. Measures of dyspnea in pulmonary rehabilitation. Multidiscip Respir Med. 2010 Jun 30;5(3):202-10. doi: 10.1186/2049-6958-5-3-202.
Dow GS, Luttick A, Fenner J, Wesche D, Yeo KR, Rayner C. Tafenoquine inhibits replication of SARS-Cov-2 at pharmacologically relevant concentrations in vitro. bioRxiv. January 2020:2020.07.12.199059. doi:10.1101/2020.07.12.199059
Jia HP, Look DC, Shi L, Hickey M, Pewe L, Netland J, Farzan M, Wohlford-Lenane C, Perlman S, McCray PB Jr. ACE2 receptor expression and severe acute respiratory syndrome coronavirus infection depend on differentiation of human airway epithelia. J Virol. 2005 Dec;79(23):14614-21. doi: 10.1128/JVI.79.23.14614-14621.2005.
Skipper CP, Pastick KA, Engen NW, Bangdiwala AS, Abassi M, Lofgren SM, Williams DA, Okafor EC, Pullen MF, Nicol MR, Nascene AA, Hullsiek KH, Cheng MP, Luke D, Lother SA, MacKenzie LJ, Drobot G, Kelly LE, Schwartz IS, Zarychanski R, McDonald EG, Lee TC, Rajasingham R, Boulware DR. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial. Ann Intern Med. 2020 Oct 20;173(8):623-631. doi: 10.7326/M20-4207. Epub 2020 Jul 16.
Velavan TP, Meyer CG. The COVID-19 epidemic. Trop Med Int Health. 2020 Mar;25(3):278-280. doi: 10.1111/tmi.13383. Epub 2020 Feb 16. No abstract available.
Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, Fu S, Gao L, Cheng Z, Lu Q, Hu Y, Luo G, Wang K, Lu Y, Li H, Wang S, Ruan S, Yang C, Mei C, Wang Y, Ding D, Wu F, Tang X, Ye X, Ye Y, Liu B, Yang J, Yin W, Wang A, Fan G, Zhou F, Liu Z, Gu X, Xu J, Shang L, Zhang Y, Cao L, Guo T, Wan Y, Qin H, Jiang Y, Jaki T, Hayden FG, Horby PW, Cao B, Wang C. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020 May 16;395(10236):1569-1578. doi: 10.1016/S0140-6736(20)31022-9. Epub 2020 Apr 29.
Worldometer. Coronavirus Update (Live). https://www.worldometers.info/coronavirus/. Accessed March 7, 2020.
Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TQ 2020_06
Identifier Type: -
Identifier Source: org_study_id
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