Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04322682

Recruitment Status : Terminated (Due to several considerations (logistical, human and budgetary), the study was stopped early.)

First Posted : March 26, 2020

Results First Posted : September 8, 2021

Last Update Posted : September 8, 2021

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

Bill and Melinda Gates Foundation

The Government of Quebec

DACIMA Software

Information provided by (Responsible Party):

Montreal Heart Institute

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition	Corona Virus Infection
Interventions	Drug: Colchicine Drug: Placebo oral tablet
Enrollment	4506

Participant Flow

Recruitment Details

Pre-assignment Details

18 patients were not included:

11 study medication was not delivered at home;
7 ineligible or condition deteriorated before study medication was delivered.


Arm/Group Title	Colchicine	Placebo
Arm/Group Description	Patients in this arm will receive s...	Patients will receive the placebo 0...
Arm/Group Description	Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Period Title: Overall Study
Started	2235	2253
Completed	2192	2189
Not Completed	43	64
Reason Not Completed
Withdrawal by Subject	33	47
Death	5	9
Lost to Follow-up	4	8
Admitted to Hospital and Intubated	1	0

Baseline Characteristics

Arm/Group Title		Colchicine	Placebo	Total
Arm/Group Description		Patients in this arm will receive s...	Patients will receive the placebo 0...	Total of all reporting groups
Arm/Group Description		Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Total of all reporting groups
Overall Number of Baseline Participants		2235	2253	4488
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Characteristics of the patients at randomisation in the intent-to-treat population.
Age, Continuous Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	2235 participants	2253 participants	4488 participants
		53.0 (47.0 to 61.0)	54.0 (47.0 to 61.0)	54.0 (47.0 to 61.0)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2235 participants	2253 participants	4488 participants
	Female	1238 55.4%	1183 52.5%	2421 53.9%
	Male	997 44.6%	1070 47.5%	2067 46.1%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2235 participants	2253 participants	4488 participants
	Hispanic or Latino	327 14.6%	349 15.5%	676 15.1%
	Not Hispanic or Latino	1869 83.6%	1872 83.1%	3741 83.4%
	Unknown or Not Reported	39 1.7%	32 1.4%	71 1.6%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2235 participants	2253 participants	4488 participants
	American Indian or Alaska Native	5 0.2%	9 0.4%	14 0.3%
	Asian	23 1.0%	20 0.9%	43 1.0%
	Native Hawaiian or Other Pacific Islander	7 0.3%	7 0.3%	14 0.3%
	Black or African American	114 5.1%	116 5.1%	230 5.1%
	White	2084 93.2%	2092 92.9%	4176 93.0%
	More than one race	2 0.1%	4 0.2%	6 0.1%
	Unknown or Not Reported	0 0.0%	5 0.2%	5 0.1%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	2235 participants	2253 participants	4488 participants
Canada		1817	1830	3647
United States		244	244	488
South Africa		0	2	2
Spain		94	94	188
Brazil		79	82	161
Greece		1	1	2
History of Respiratory Disease Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2235 participants	2253 participants	4488 participants
	Yes	583 26.1%	605 26.9%	1188 26.5%
	No	1652 73.9%	1647 73.1%	3299 73.5%
	Not Reported	0 0.0%	1 0.0%	1 0.0%
History of Diabetes Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2235 participants	2253 participants	4488 participants
	Yes	444 19.9%	450 20.0%	894 19.9%
	No	1791 80.1%	1803 80.0%	3594 80.1%
Body Mass Index (BMI) Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	2235 participants	2253 participants	4488 participants
		30.0 (6.2)	30.0 (6.3)	30.0 (6.2)

Outcome Measures

1.Primary Outcome


Title	Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.
Description	The primary endpoint will be the composite of death or hospitalization...
Description	The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization.
Time Frame	30 days post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	Patients in this arm will receive s...	Patients will receive the placebo 0...
Arm/Group Description:	Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Overall Number of Participants Analyzed	2235	2253
Measure Type: Count of Participants Unit of Measure: Participants
	104 4.7%	131 5.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colchicine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.081
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95.1% 0.61 to 1.03
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Number of Deaths in the 30 Days Following Randomization.
Description	The secondary endpoint consisted of two components of the composite pr...
Description	The secondary endpoint consisted of two components of the composite primary endpoint and included death in the 30 days following randomization.
Time Frame	30 days post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	Patients in this arm will receive s...	Patients will receive the placebo 0...
Arm/Group Description:	Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Overall Number of Participants Analyzed	2235	2253
Measure Type: Count of Participants Unit of Measure: Participants
	5 0.2%	9 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colchicine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.291
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95% 0.19 to 1.67
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.
Description	The secondary endpoint consisted of two components of the composite pr...
Description	The secondary endpoint consisted of two components of the composite primary endpoint and included hospitalization due to COVID-19 infection in the 30 days following randomization.
Time Frame	30 days post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	Patients in this arm will receive s...	Patients will receive the placebo 0...
Arm/Group Description:	Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Overall Number of Participants Analyzed	2235	2253
Measure Type: Count of Participants Unit of Measure: Participants
	101 4.5%	128 5.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colchicine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.077
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% 0.60 to 1.03
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization.
Description	The secondary endpoint is the need for mechanical ventilation in the 3...
Description	The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.
Time Frame	30 days post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	Patients in this arm will receive s...	Patients will receive the placebo 0...
Arm/Group Description:	Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Overall Number of Participants Analyzed	2235	2253
Measure Type: Count of Participants Unit of Measure: Participants
	11 0.5%	21 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colchicine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.080
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95% 0.25 to 1.09
	Estimation Comments	[Not Specified]

5.Other Pre-specified Outcome


Title	Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization in the Subgroup of Patients With PCR-confirmed COVID-19.
Description	In the prespecified analysis of the 4159 patients with Covid-19 confir...
Description	In the prespecified analysis of the 4159 patients with Covid-19 confirmed by PCR, the primary endpoint (composite of death or hospitalization due to Covid-19 infection in the 30 Days following randomization) was compared between the two treatment groups.
Time Frame	30 Days post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	Patients in this arm will receive s...	Patients will receive the placebo 0...
Arm/Group Description:	Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Overall Number of Participants Analyzed	2075	2084
Measure Type: Count of Participants Unit of Measure: Participants
	96 4.6%	126 6.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colchicine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.042
	Comments	P-Value is for the comparison of the treatment group within patients with Covid-19 confirmed by PCR.
	Method	Regression, Logistic
	Comments	Logistic-regression model including the treatment group, the PCR-confirmed Covid-19 subgroup factor (yes/no) and their interaction was performed.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95% 0.57 to 0.99
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	From randomization/baseline to End of Study visit which planned 30 days after baseline.
Adverse Event Reporting Description	2 additional Serious Adverse Events were added to the definition : cancer; overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.

Arm/Group Title	Colchicine	Placebo
Arm/Group Description	Patients in this arm will receive s...	Patients will receive the placebo 0...
Arm/Group Description	Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
All-Cause Mortality
	Colchicine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/2195 (0.23%)	9/2217 (0.41%)
Serious Adverse Events Serious Adverse Events
	Colchicine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	108/2195 (4.92%)	139/2217 (6.27%)
Cardiac disorders
Arrhythmia ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Atrial fibrillation ^* 1	1/2195 (0.05%)	1/2217 (0.05%)
Myocardial infarction ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Pericarditis ^* 1	0/2195 (0.00%)	2/2217 (0.09%)
Tachycardia ^* 1	2/2195 (0.09%)	1/2217 (0.05%)
Gastrointestinal disorders
Abdominal pain ^* 1	1/2195 (0.05%)	1/2217 (0.05%)
Gastrointestinal disorder ^* 1	3/2195 (0.14%)	2/2217 (0.09%)
Gastrointestinal haemorrhage ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Pancreatitis ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
General disorders
Death ^* 1	1/2195 (0.05%)	1/2217 (0.05%)
General physical health deterioration ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Pyrexia ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Immune system disorders
Hypersensitivity ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Infections and infestations
Appendicitis ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Corona virus infection ^* 1	2/2195 (0.09%)	0/2217 (0.00%)
Diverticulitis ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Pneumonia ^* 1	63/2195 (2.87%)	92/2217 (4.15%)
Pneumonia bacterial ^* 1	4/2195 (0.18%)	2/2217 (0.09%)
Pneumonia viral ^* 1	2/2195 (0.09%)	2/2217 (0.09%)
Pyelonephritis ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Septic shock ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Viral infection ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Investigations
Blood magnesium abnormal ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Oxygen saturation decreased ^* 1	0/2195 (0.00%)	2/2217 (0.09%)
Metabolism and nutrition disorders
Dehydration ^* 1	3/2195 (0.14%)	6/2217 (0.27%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Nervous system disorders
Aphasia ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Cerebrovascular accident ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Dizziness ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Headache ^* 1	0/2195 (0.00%)	3/2217 (0.14%)
Loss of proprioception ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Multiple sclerosis ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Neuropathy peripheral ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Syncope ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Renal and urinary disorders
Acute kidney injury ^* 1	1/2195 (0.05%)	1/2217 (0.05%)
Nephrolithiasis ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Respiratory, thoracic and mediastinal disorders
Bronchitis ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Dyspnoea ^* 1	5/2195 (0.23%)	4/2217 (0.18%)
Dyspnoea at rest ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Interstitial lung disease ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Pleural effusion ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Pneumonia ^* 1	0/2195 (0.00%)	1/2217 (0.05%)
Pneumothorax ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Pulmonary embolism ^* 1	11/2195 (0.50%)	2/2217 (0.09%)
Respiratory distress ^* 1	12/2195 (0.55%)	13/2217 (0.59%)
Respiratory failure ^* 1	0/2195 (0.00%)	2/2217 (0.09%)
Vascular disorders
Haemorrhage ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
1 Term from vocabulary, MedDRA 22.1 * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Colchicine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	524/2195 (23.87%)	328/2217 (14.79%)
Gastrointestinal disorders
Abdominal discomfort ^* 1	7/2195 (0.32%)	3/2217 (0.14%)
Abdominal distension ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Abdominal pain ^* 1	28/2195 (1.28%)	18/2217 (0.81%)
Abdominal pain lower ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Constipation ^* 1	2/2195 (0.09%)	7/2217 (0.32%)
Diarrhoea ^* 1	300/2195 (13.67%)	161/2217 (7.26%)
Dry mouth ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Dyspepsia ^* 1	8/2195 (0.36%)	13/2217 (0.59%)
Epigastric discomfort ^* 1	1/2195 (0.05%)	2/2217 (0.09%)
Faeces soft ^* 1	10/2195 (0.46%)	2/2217 (0.09%)
Flatulence ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Gastric disorder ^* 1	12/2195 (0.55%)	8/2217 (0.36%)
Gastritis ^* 1	1/2195 (0.05%)	1/2217 (0.05%)
Gastrointestinal disorder ^* 1	114/2195 (5.19%)	72/2217 (3.25%)
Gastrointestinal haemorrhage ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Gastrooesophageal reflux disease ^* 1	3/2195 (0.14%)	2/2217 (0.09%)
Nausea ^* 1	43/2195 (1.96%)	47/2217 (2.12%)
Pancreatitis ^* 1	1/2195 (0.05%)	0/2217 (0.00%)
Vomiting ^* 1	6/2195 (0.27%)	4/2217 (0.18%)
1 Term from vocabulary, MedDRA 22.1 * Indicates events were collected by non-systematic assessment

Limitations and Caveats

Due to several considerations (logistical, human and budgetary), the study was stopped early. Furthermore, stopping the study after approximately 4500 patients had completed their 30-day follow-up would allow to communicate results in January 2021 in the hope of preventing complications of COVID-19 in ambulatory patients, instead of delivering results anywhere between April and October 2021 at a time when vaccination efforts might be successful.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Jean-Claude Tardif (Principle Investigator)
Organization:	Montreal Heart Institute
Phone:	514 376-3330 ext 3612
EMail:	jean-claude.tardif@icm-mhi.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.

Tardif JC, Bouabdallaoui N, L'Allier PL, Gaudet D, Shah B, Pillinger MH, Lopez-Sendon J, da Luz P, Verret L, Audet S, Dupuis J, Denault A, Pelletier M, Tessier PA, Samson S, Fortin D, Tardif JD, Busseuil D, Goulet E, Lacoste C, Dubois A, Joshi AY, Waters DD, Hsue P, Lepor NE, Lesage F, Sainturet N, Roy-Clavel E, Bassevitch Z, Orfanos A, Stamatescu G, Gregoire JC, Busque L, Lavallee C, Hetu PO, Paquette JS, Deftereos SG, Levesque S, Cossette M, Nozza A, Chabot-Blanchet M, Dube MP, Guertin MC, Boivin G; COLCORONA Investigators. Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial. Lancet Respir Med. 2021 Aug;9(8):924-932. doi: 10.1016/S2213-2600(21)00222-8. Epub 2021 May 27.

Layout table for additonal information

Responsible Party:	Montreal Heart Institute
ClinicalTrials.gov Identifier:	NCT04322682
Other Study ID Numbers:	MHIPS-2020-001 3R01HL146206-02S1 ( U.S. NIH Grant/Contract )
First Submitted:	March 23, 2020
First Posted:	March 26, 2020
Results First Submitted:	August 10, 2021
Results First Posted:	September 8, 2021
Last Update Posted:	September 8, 2021

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