COVID19

Coronavirus Infection

Pregnancy Disease

Severe Acute Respiratory Syndrome

Instituto Materno Infantil Prof. Fernando Figueira

Northeast COVID-19 and Pregnancy Study Group

Clinical and Laboratory Predictors of COVID-19 Progression and Maternal and Perinatal Outcomes in Infected Pregnant and Postpartum Women in Six Reference Centers in the Northeast of Brazil

Refers to a woman who almost died, but survived a serious complication that occurred during pregnancy, childbirth or within 42 days after termination of the pregnancy, depending on the presence of at least one of the criteria adopted by the World Health Organization ( WHO). Variable, categorical and dichotomous yes / no type.

It is the death of a woman during pregnancy or within 42 days after the end of the pregnancy or due to measures taken in relation to the pregnancy, but not due to accidental or incidental causes. Variable, categorical and dichotomous yes / no type.

It refers to the newborn classified with severe morbidity by pragmatic criteria (Apgar <7 in the 5th minute, birth weight <1,750 grams or gestational age <33 weeks) or conduct (parenteral antibiotic therapy - up to 7 days and before the 28th day of life, nasal CPAP, intubation, up to 7 days and before the 28th day of life, phototherapy within 24 hours of life, cardiopulmonary resuscitation, use of vasoactive drugs, use of anticonvulsants, use of blood products, use of corticosteroids to treat refractory hypoglycemia and surgery) but who survived the 27th day of life, included. Yes / no categorical and dichotomous variable.

Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.

Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable

Intrauterine death, corresponding to the birth of a fetus without signs of life, weighing 500 grams or more. Dichotomous categorical variable of the yes / no type.

Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.

Calculated based on the date of birth recorded in the medical record, hospital identification data, or according to the patient's information, in full years. Numerical and discrete variable.

maternal weight before pregnancy, in kilogram (kg), according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.

expressed, in meters, according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.

classified according to pre-gestational BMI: low weight grade III (≤ 16.00), low weight grade II (≥ 16.00 to <16.99), low weight grade I (≥ 17 , 00 to <18.49), ideal weight (≥ 18.50 to <24.99), overweight (≥ 25.00 to <29.99), grade I obesity (≥ 30.00 to <34.99) , grade II obesity (≥35.00 to <39.99) and grade III obesity (≥ 40.00).

expressed in Kg / m2, calculated by weight (kg) divided by height (m) squared. Numeric and continuous variable.

according to the patient's self-declaration and collected according to information and / or recorded in the medical record or prenatal card in black, white, brown, yellow and indigenous.

defined as the number of people, regardless of age, living in the same household, collected according to the patient's information. Numerical and discrete variable.

collected according to the patient's information as the sum of the monthly income of all members living in the household, including benefits from social programs and informal income. Categorized in: up to 1 minimum wage; 1 to 2 minimum wages; 3 to 5 minimum wages; more than 5 minimum wages. Numerical and discrete variable.

as informed by the patient, recorded in medical records or prenatal card and categorized as illiterate (zero), elementary school (one to nine years), high school (10 to 12 years) and higher education (> 12 years) ). Numerical and discrete variable.

as declared by the patient and noted on the medical record or prenatal card, later categorized as: health, education, general services, home, domestic, student, merchant or commerce, security, self-employed, economy, tourism, music, nutrition, computers, journalism, engineering and others.

as declared by the patient, as being a formal job or not, which presents any monthly financial income. Yes / no categorical and dichotomous variable.

declared by the patient and recorded in medical records or prenatal card in: single, married, stable, separated and widowed.

as informed by the patient and recorded in medical records, related to the city where she lives, defined as Recife, metropolitan region (Jaboatão dos Guararapes, Olinda, Paulista, Moreno, Igarassu, Abreu e Lima, Camaragibe, Cabo de Santo Agostinho, São Lourenço da Mata, Araçoiaba, Itamaracá Island, Ipojuca and Itapissuma), interior and other states.

according to the belief declared by the patient and categorized into: atheist, catholic, evangelical, spiritist, Anglican charismatic and others.

smoking, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

habit of drinking alcoholic beverages, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

use of non-legal drugs, such as marijuana, cocaine, crack and the like, regardless of the amount, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

number of previous pregnancies, including the current one, regardless of the gestational outcome (abortion, delivery, number of fetuses, ectopic pregnancy or fetal death), as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of previous deliveries with fetuses over 500g and / or gestational age greater than 22 weeks, regardless of multiple gestation, perinatal death or delivery, as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of previous deliveries with fetuses over 500g and / or gestational age greater than the 22nd week, by cesarean section, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of previous births with fetuses above 500g and / or gestational age greater than 22 weeks, vaginally, regardless of whether instrumental, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of interruptions of pregnancy with fetuses below 500g and / or gestational age below 22 weeks, regardless of being spontaneous, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of children who remain alive, regardless of the cause of death, as informed by the patient and noted in medical records or prenatal card. Numerical and discrete variable.

as informed by the patient or noted on the prenatal card and medical record, the number of consultations performed during prenatal care. Numerical and discrete variable.

gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the onset of flu-like signs and symptoms. Numerical and discrete variable.

number of days after birth of the onset of flu-like signs and symptoms. Numerical and discrete variable.

number of days the patient had signs and symptoms of flu-like syndrome and its complications. Numerical and discrete variable.

when the patient declared that at the beginning of the signs and symptoms she was separated / isolated at home without any contact with healthy people, including not even going out for essential purchases, for a period of 14 days. Yes / No categorical and dichotomous variable.

it is a measure of community restraint, adopted in some cases, to prevent the spread of a certain contagious disease. Considered when the patient declared that she was at home, leaving only what was necessary for essential purchases, before the onset of signs and symptoms. Yes / No categorical and dichotomous variable.

when the patient declared that she had contact with people infected with COVID-19 and / or traveled to places considered to be the epicenter of the disease, but even asymptomatic, she stayed home without contact with other people, including not even going out for essential purchases, for a period of seven to 14 days. Yes / No categorical and dichotomous variable.

when there is a need for hospitalization due to flu-like syndrome and / or its complications, excluding hospitalizations due to obstetric complications and includes all participants, especially pregnant women monitored during prenatal care. Yes / No categorical and dichotomous variable.

day of hospitalization due to flu syndrome and / or complications. Numerical and discrete variable.

length of stay, in days, as described in the medical record. Numerical and discrete variable.

As reported by the patient (dry cough, day of onset of dry cough, productive cough, day of onset of productive cough, coryza, day of onset of runny nose, body pain, day of onset of body pain, abdominal pain, day of onset of abdominal pain, chest pain, day of onset of chest pain, headache, day of onset of headache, dyspnoea, day of onset of dyspnoea, subfebrile state, day of onset of subfebrile state, fever, day of onset of fever, diarrhea , day of onset of diarrhea, sore throat, day of onset of sore throat, taste change, day of onset of taste change, smell change, day of onset of smell change, asthenia, day of onset of asthenia , axillary temperature, oxygen saturation).

result of RT-PCR in the diagnosis of COVID-19, by means of blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.

result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.

result of the RT-PCR of the viral panel in the differential diagnosis of flu syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.

result in the diagnosis of COVID-19, by means of blood, according to the usual technique, being categorized as positive, negative and indeterminate.

result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.

result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 5th day of signs and symptoms. Numeric and continuous variable.

result of IgG COVID-19 serology, by means of blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 14th day of signs and symptoms. Numeric and continuous variable.

rom the first exam (day zero). Describe the subsequent days. Numerical and discrete variable.

after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.

substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, from the beginning of the flu syndrome or COVID- 19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).

day of the first cytokine dosage from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

day of the first blood count from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first hemoglobin measured in maternal blood, in g / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 11.0g / dL and ≤ 16.0g / dL. Numeric and continuous variable.

value of the first leukocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 4,000 / mm3 and ≤ 11,000 / mm3. Numerical and discrete variable.

when the rod / segment ratio is greater than 1/16 and / or the presence of young cells (promyelocytes, myelocytes, metamyelocytes) occurs, starting with the flu syndrome and in the period of the syndrome. Yes / No categorical and dichotomous variable.

value of the first platelet measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 150,000 / mm3 and ≤ 400,000 / mm3. Numerical and discrete variable.

value of the first typical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 1,050 / mm3 and ≤ 3,850 / mm3. Numerical and discrete variable.

value of the first atypical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 0 / mm3 and ≤ 220 / mm3. Numerical and discrete variable.

day of the first coagulogram from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first TB measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, being normal from 60s to 180s. Numerical and discrete variable.

value of the first CT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

value of the first TD measured in maternal blood, in seconds (s), from the flu syndrome and in the period of the syndrome, with a value of up to 11.3s being normal. Numerical and discrete variable.

value of the first APTT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, with a value of up to 30.5s being normal.

value of the first INR measured in maternal blood, from the flu syndrome and the period of the syndrome, being normal between 2 and 3. Numerical and discrete variable.

day of the first urea from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.

day of the first creatinine from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numerical and discrete variable.

defined as aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP), from the beginning of the flu syndrome or COVID-19 on syndrome period.

day of the first VSH from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.

day of the first CRP from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first CRP measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.

day of the first D-dimer from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first D-dimer dosed in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

day of the first DHL from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first DHL measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.

day of the first alkaline phosphatase from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.

day of the first troponin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first troponin measured in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.

day of the first ferritin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

alue of the first ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

defined as total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.

day of the first blood culture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

result of the first blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.

day of the first uroculture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

result of the first uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

worst result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, of according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.

Result of the worst result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 5th day of signs and symptoms. Numeric and continuous variable.

worst result of IgG COVID-19 serology, performed using blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each kit serological test, performed after the 14th day of signs and symptoms. Numeric and continuous variable.

substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A , IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, being the worst maternal result, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).

day of the performance of the worst urea result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the worst result of urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.

day of the worst creatinine result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the worst result of creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numeric and discrete variable.

defined as the worst outcome of aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP) from the onset of the flu syndrome or COVID- 19 and in the period of the syndrome.

Leila Katz

Principal Investigator

Ruxolitinib will be administered orally at a dose of 10 mg twice daily (both PV and ET) for two consecutive years.

BAT may include all currently used treatment options. BAT is at the choice of the investigator (monotherapy with i.e. hydroxyurea, anagrelide, interferon, busulfan, immunomodulators etc). BAT will be administrated for two consecutive years.

Polycythemia Vera (PV)

Essential Thrombocythemia (ET)

Ruxolitinib is a JAK1/2-specific tyrosine kinase inhibitor (TKI) which has been approved for the treatment of symptomatic myelofibrosis. The compound was shown to be superior to hydroxyurea in reducing splenomegaly and constitutional symptoms.

Ruxolitinib

BAT is at the choice of the investigator (monotherapy with i.e. hydroxyurea, anagrelide, interferon, busulfan, immunomodulators etc).

Universitätsmedizin Mannheim III. Medizinische Klinik Hämatologie und Internistische Onkologie

Universitätsklinikum Ulm Klinik für Innere Medizin III

Rems-Murr Klinikum Winnenden

Studienzentrum Aschaffenburg

III. Medizinischen Klinik des Klinikums rechts der Isar der TU München

Klinikum Nürnberg Nord Medizinische Klinik 5

Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik

Universitätsklinikum Bonn Medizinische Klinik und Poliklinik III

Johanniter-Krankenhaus Rheinhausen GmbH Hämatologie / Internistische Onkologie / Tagesklinik

Universitätsklinikum Düsseldorf Klinik für Hämatologie, Onkologie und Klinische Immunologie

Universitätsklinikum Essen Klinik für Hämatologie

Mühlenkreiskliniken Johannes Wesling Klinikum Minden Klinik für Hämatologie, Onkologie und Palliativmedizin

Zentralklinikum Medizinische Klinik A Hämatologie, Hämostaseologie, Onkologie und Pneumologie

Marienhospital

Zentrum für ambulante Hämatologie und Onkologie (ZAHO)

Uniklinik RWTH Aachen

InVO - Institut für Versorgungsforschung in der Onkologie

Universitätsklinikum Magdeburg

Universitätsklinikum Halle (Saale)

Klinikum Chemnitz gGmbH Klinik für Innere Medizin III

Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

Charité Universitätsmedizin Berlin Med. Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie

Universitätsklinikum Freiburg - Klinik für Innere Medizin I

Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Onkologie, Hämatologie und KMT mit Sektion Pneumologie

Universitätsklinik Jena - Klinik für Innere Medizin II

Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik I

UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Klinik für Hämatologie und Onkologie, Campus Lübeck

The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia

Ruxolitinib Versus Best Available Therapy in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia - The Ruxo-BEAT Trial

The rate of complete clinicohematologic response rate (CHR) as defined by Barosi et al Blood 2009

RWTH Aachen University

Novartis Pharmaceuticals

Part A: RG7388 as a single agent; given at a starting dose of 100 mg each day for five days for the first cycle which will be 56 days.
Part B: combination of RG7388 and Pegasys if subject does not achieve at least a PR by the end of 3 cycles of single agent RG7388

Polycythemia Vera

Essential Thrombocythemia

RG7388 is supplied as film-coated tablets at dosage strengths of 50 mg, 200 mg, 300mg and 400 mg.

RG7388

PEGASYS is supplied as a clear, sterile solution for subcutaneous (SQ) injection available in prefilled syringes. weekly doses at 45ug subcutaneously

Pegasys

Georgetown University Medical Center

Icahn School of Medicine at Mount Sinai

Wake Forest University Baptist Medical Center

Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia

Open Label Phase I Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia (With Pilot Feasibility Study in Combination With Pegylated Interferon Alfa 2a for Patients Who do Not Respond to the Single Agent at Each Dose Level)

polycythemia/diarré

Northeast COVID-19 and Pregnancy Study Group

The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia

Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia

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