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Policy Responses Against the COVID-19 Pandemic in Latin America

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ClinicalTrials.gov Identifier: NCT04816318
Recruitment Status : Not yet recruiting
First Posted : March 25, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Sebastián Peña, University of Chile

Brief Summary:

Latin America is one of the worst-hit areas from the COVID-19 pandemic worldwide. Policy responses to COVID-19 in Latin America have sought to reduce viral spread, increase the capacity of the health system response, mitigate negative consequences, and strengthen governance. Few studies have examined the effectiveness of COVID-19 policies in Latin America or explored subnational variation in their effectiveness.

In this observational study, the investigators will use a two-stage interrupted time series to estimate the effectiveness of nonpharmaceutical interventions in third-tier subnational units on SARS-COV2 transmission and COVID-19 mortality in Latin America. The investigators will estimate the effects in each local government, and then run a random-effects meta-analysis to obtain pooled effects for each intervention (and combinations of) and heterogeneity estimates. Finally, the investigators will explore potential explanations for the heterogeneity at the local level.


Condition or disease Intervention/treatment
Covid19 Infectious Disease Death SARS-CoV Infection Other: Social and public health measures against COVID-19 Other: Control

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Policy Responses Against the COVID-19 Pandemic in Latin America: Interrupted Series Analyses of Local Governments
Estimated Study Start Date : April 28, 2021
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Social and public health measures against COVID-19
Public Health and Social measures against COVID-19. This group refers to the population exposed to public health and social measures against COVID-19
Other: Social and public health measures against COVID-19
  1. Viral spread (for both outcomes) 1.1. Total lockdown 1.2 Partial lockdown (geographical, step-wise/graduated response) 1.3 Curfew 1.4 School closure 1.5 Closure of shopping malls, gyms, churches, parks 1.6 Remote work 1.7 Restrictions to national/subnational mobility 1.8 Prohibition of mass gatherings
  2. Health systems response (for COVID-19 deaths outcome) 2.1 Interventions to increase testing capacity 2.2 Interventions to increase the number of ICU/critical beds
  3. Mitigation strategies (for both outcomes) 3.1 Direct social assistance (in-kind/cash) 3.2 Cash transfer 3.3 Withdrawal of pension funds
Other Name: Non-pharmaceutical interventions against COVID-19

Control
The comparator is the pre-intervention period
Other: Control
The comparator is a counterfactual outcome defined as the projection of the pre-intervention trend to simulate what would have happened if the policy had not occurred (see Statistical Analysis Plan for definitions)




Primary Outcome Measures :
  1. 7-day moving average of daily confirmed cases of COVID-19/SARS-CoV-2 [ Time Frame: Intervention period of up to 30 days (intervention periods lower than 7 days will be considered as a combined set of interventions) ]
  2. Time-varying reproductive number of confirmed cases of COVID-19/SARS-CoV-2 [ Time Frame: Intervention period of up to 30 days (intervention periods lower than 7 days will be considered as a combined set of interventions) ]
  3. 7-day moving average of daily confirmed deaths of COVID-19/SARS-CoV-2 [ Time Frame: Intervention period of up to 30 days (intervention periods lower than 7 days will be considered as a combined set of interventions) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study covers the population of included countries in Latin America. Preliminarily this represents nine countries, covering 80.9% of the total population in Latin America
Criteria

Inclusion Criteria:

  • Country will be eligible if they are (1) Spanish or Portuguese speaking countries in Latin America, (2) availability of open data at the subnational level for any of the outcomes

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816318


Contacts
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Contact: Sebastián Peña, MD, PhD +358452451360 sebastian.penafajuri@thl.fi

Locations
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Chile
Escuela de Salud Pública
Santiago, Región Metropolitana, Chile, 8380453
Sub-Investigator: Helena Morais, MEcon         
Sub-Investigator: Maria José Monsalves, PhD         
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Sebastián Peña, MD, PhD Escuela de Salud Pública
Principal Investigator: Cristóbal Cuadrado, MD, PhD Escuela de Salud Pública
  Study Documents (Full-Text)

Documents provided by Sebastián Peña, University of Chile:
Study Protocol  [PDF] March 23, 2021
Statistical Analysis Plan  [PDF] March 10, 2021

Additional Information:
Publications:
United Nations Department of Economic and Social Affairs. World Social Report 2020: Inequality in a rapidly changing world. New York, United States: United Nations; 2020
Martinez-Gutierrez S., Cuadrado C., Peña S. Chile's response to the coronavirus pandemic. 2020. Available at: https://www.cambridge.org/core/blog/2020/04/11/chiles-response-to-the-coronavirus-pandemic/ (accessed April 12, 2020)
Candido DS, Claro IM, de Jesus JG, Souza WM, Moreira FRR, Dellicour S, Mellan TA, du Plessis L, Pereira RHM, Sales FCS, Manuli ER, Thézé J, Almeida L, Menezes MT, Voloch CM, Fumagalli MJ, Coletti TM, da Silva CAM, Ramundo MS, Amorim MR, Hoeltgebaum HH, Mishra S, Gill MS, Carvalho LM, Buss LF, Prete CA Jr, Ashworth J, Nakaya HI, Peixoto PS, Brady OJ, Nicholls SM, Tanuri A, Rossi ÁD, Braga CKV, Gerber AL, de C Guimarães AP, Gaburo N Jr, Alencar CS, Ferreira ACS, Lima CX, Levi JE, Granato C, Ferreira GM, Francisco RS Jr, Granja F, Garcia MT, Moretti ML, Perroud MW Jr, Castiñeiras TMPP, Lazari CS, Hill SC, de Souza Santos AA, Simeoni CL, Forato J, Sposito AC, Schreiber AZ, Santos MNN, de Sá CZ, Souza RP, Resende-Moreira LC, Teixeira MM, Hubner J, Leme PAF, Moreira RG, Nogueira ML; Brazil-UK Centre for Arbovirus Discovery, Diagnosis, Genomics and Epidemiology (CADDE) Genomic Network, Ferguson NM, Costa SF, Proenca-Modena JL, Vasconcelos ATR, Bhatt S, Lemey P, Wu CH, Rambaut A, Loman NJ, Aguiar RS, Pybus OG, Sabino EC, Faria NR. Evolution and epidemic spread of SARS-CoV-2 in Brazil. Science. 2020 Sep 4;369(6508):1255-1260. doi: 10.1126/science.abd2161. Epub 2020 Jul 23.
Peña S., Cuadrado C., Rivera-Aguirre A., Hasdell R., Nazif-Munoz J., Yusuf M. et al. PoliMap: A taxonomy proposal for mapping and understanding the global policy response to COVID-19. OSF Preprint. 2020. Available at: https://osf.io/h6mvs (accessed March 22, 2021)

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Responsible Party: Sebastián Peña, Co-investigator, University of Chile
ClinicalTrials.gov Identifier: NCT04816318    
Other Study ID Numbers: ANID-COVID 0960
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study uses open access data available at the municipal/district/canton level. The investigators will include the data and statistical code as a Supplementary Appendix in the published papers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: The Study Protocol and SAP will be available in the project OSF repository upon publication of the registration in ClinicalTrials.gov. The Statistical code will be published as a Supplementary Appendix with the publish paper or preprint.
Access Criteria: Any interested party can access the data and documents
URL: https://osf.io/8ne7g/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sebastián Peña, University of Chile:
Effectiveness
Health policy
Heterogeneity
Latin America
Additional relevant MeSH terms:
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COVID-19
Communicable Diseases
Infections
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes